Product Advisories
Important Product Information
We pursue excellence in every product we make. We have a strong history of product safety and reliability, and we remain dedicated to developing technology and products that save and improve the lives of patients worldwide.
We take our responsibilities as a leading device manufacturer very seriously and recognize our primary responsibility is to ensure that our devices are of the highest quality and function safely and properly.
Our commitment to business integrity means we quickly share with professionals and patients the important information they need about our products’ performance and safety. These product advisories and communications remain available for review.
Medical Device Field Safety Notice: Amplatzer TorqVue LP Delivery System (TVLP) and Amplatzer TorqVue LP Catheter (TVLPC) – March 2025
Abbott is notifying customers of an issue related to certain 4F Amplatzer™ TorqVue™ LP Delivery System (TVLP) and 4F Amplatzer™ TorqVue™ LP Catheter (TVLPC) with a potential for a small leak to occur on the catheter shaft.
Medical Device Recall: HeartMate Mobile Power Unit (MPU) Performance Issues – March 2025
Abbott is notifying hospital customers of occurrences where certain units of the HeartMate™ Mobile Power Unit (MPU), as used with HeartMate 3™ Left Ventricular Assist System (LVAS) and HeartMate II™ LVAS, have experienced sudden, unexpected performance issues such as not turning on, unprompted shut down, or suddenly turning off and restarting, with the System Controller indicating a Yellow Wrench alarm or “No External Power” alarm. These issues have been linked to an electrical component in certain MPUs distributed between April 2024 and February 2025. Abbott has asked that clinicians review the issue with impacted patients and provide a patient letter as applicable and discontinue the use of impacted units currently experiencing the performance issues described. Replacement of impacted MPU devices will begin in June 2025 or earlier when sufficient inventory is available.
Safety Notification: Assurity, Endurity, Zenex, Zenus Pacemakers – Pacemaker Epoxy Mixing (February 2025)
In February 2025, Abbott provided a Safety Notification for a subset of Assurity, Endurity, Zenex*, and Zenus* pacemakers due to an issue that may result in incomplete mixing of epoxy during manufacturing. This specific manufacturing equipment is no longer in use.
Affected devices vary based on commercial availability in each region.
* Zenex and Zenus were distributed in Japan only.
Medical Device Correction: Follow Up Notification - CardioMEMS Patient Electronics System and Merlin.net Patient Care Network - November 2024
Follow-up from the previous customer notification in October 2024. During the migration, 3.9% of CardioMEMS™ Patient Electronics Systems (PES) CM1100 were reverted to an outdated configuration file in the cloud database that may have resulted in incorrect pulmonary artery (PA) pressure readings. Configuration files are utilized by the PES to interface with the implanted CardioMEMS™ PA Sensor and translate raw sensor data to PA pressures. Abbott is recommending replacement of the affected PES that are resisting correction of their configuration file.
Medical Device Correction: Merlin™ Patient Care System (PCS) Software - November 2024
Abbott is notifying customers of programmer software anomaly that may be encountered in a very specific circumstance during finalization of the AVEIR™ DR Leadless Pacemaker (LP) System. We have developed updated Merlin and Merlin 2 PCS software (Model 3330 v28.2.1 rev 2 or higher) which corrects this issue. Your Abbott Representative will upgrade your programmer software. Software version numbers and availability timeframe may vary per region.
AMERICAS
EUROPE
ASIA PACIFIC
Medical Device Correction: HeartMate 3 System Controller — July 2024
Abbott is notifying customers of a potential issue identified with HeartMate 3™ System Controllers. Abbott has identified that there is a potential for the specific controllers to have a lifted User Interface (UI) membrane that when present, is observed along the edge of the controller housing, near the Display Button. The product is not being removed from the field. This letter contains important information and recommendations regarding this issue.
EUROPE, MIDDLE EAST AND AFRICA
Medical Device Correction: 2nd Generation CentriMag Primary Console Surge Immunity — May 2024
Abbott is notifying users of a potential issue with the CentriMag™ Console (2nd Generation CentriMag Primary Console) where if subjected to a power surge above 1.8kV and up to 2.0 kV, the CentriMag Console may shut down completely without alarm. The letter contains important information and recommendations on how to use CentriMag Console if the system shuts down without an alarm.
EUROPE, MIDDLE EAST AND AFRICA
Medical Device Correction: HeartMate System Monitor — May 2024
Abbott notified customers regarding complaints received for the HeartMate™ System Monitor where the screen may display atypical behavior. The distributed letter provides recommendations and guidance to follow if screen issues are observed. The System Monitor is not being removed from the field and does not need to be returned to Abbott.
EUROPE, MIDDLE EAST AND AFRICA
Medical Device Correction: AVEIR VR Leadless Pacemakers — April 2024
An urgent Medical Device Correction was issued to inform customers of a potential for electromagnetic interference (EMI) to cause an inadvertent mode change in a subset of AVEIR™ VR LSP112V devices manufactured with firmware version 19.05.00. This issue is corrected through a firmware upgrade.
AMERICAS
Medical Device Correction: HeartMate 3 LVAS Kits – March 2024
Abbott is notifying customers of complaints of blood leaking out of the left ventricle or air entering the left ventricle or LVAD at the seal interface between the HeartMate 3™ LVAS inflow cannula and the titanium apical cuff. The blood leak or air entrainment has only been observed during the implantation procedure. The letter contains important information when observing blood leaking from the LVAD or air passing into the left ventricle and LVAD. There is no need to return any product to Abbott.
EUROPE, MIDDLE EAST AND AFRICA
Beginning in February 2025, Abbott is notifying customers of an important update to the communication sent in 2024 within the attached letter. This update is related to a design solution intended to mitigate the occurrence of this issue.
Medical Device Correction: HeartMate LVAS Kits and Outflow Grafts – February 2024
Abbott is notifying customers of a planned update to our Instructions for Use associated with observed outflow graft deformation known as “Extrinsic Outflow Graft Obstruction” (EOGO) associated with the HeartMate 3™ Left Ventricular Assist System (LVAS) and HeartMate II™ LVAS. The letter contains important information on how to recognize EOGO and recommended steps to diagnose EOGO. There is no need to return any product to Abbott.
EUROPE, MIDDLE EAST AND AFRICA
Field Safety Notice: HeartMate Touch Communication System – January 2024
A Field Safety Notice was issued on January 3, 2024, indicating that the HeartMate Touch™ Communication System Application Ver. 1.0.32 could result in an unintentional start/stop of the HeartMate 3 Left Ventricular Assist Device (LVAD)
EUROPE, MIDDLE EAST AND AFRICA
Medical Device Field Safety Notices: CardioMEMS Patient Electronics System — October 2023
Abbott is notifying the clinicians with a patient letter of an issue with the CardioMEMS™ Patient Electronics System (PES) and providing additional instructions to supplement the Instructions for Use. PES units manufactured from December 2017 onward that include the power connector plug housed in the connector cover in the back of the device may became frayed or damaged over time. Damage and fraying of the power connector plug can occur with repeated bending or manipulation beyond 90 degrees. This communication is to bring awareness, share the actions Abbott is taking, emphasize existing Instructions for Use and to provide important additional instructions to supplement the Instructions For Use.
It is safe for patients to continue using their device when the power connector plug is undamaged and properly connected to the power adapter cable secured to the back of the PES.
Safety Notification: Assurity and Endurity Pacemaker Equipment - October 2023
In October 2023, Abbott provided a Safety Notification for a limited subset of 455 Assurity and Endurity pacemakers distributed in Europe that may be affected by a manufacturing process variation within a single piece of equipment. This specific manufacturing equipment is no longer in use.
Medical Device Correction: HeartMate 3 LVAS Kits and Apical Coring Knife — August 2023
Abbott is notifying customers of a finding with the HeartMate Apical Coring Knife provided with the HeartMate 3 Left Ventricular Assist System (LVAS) kits and distributed separately.
Medical Device Correction: HeartMate Touch Communication System — August 2023
Abbott is notifying customers about a single reported event where the HeartMate Touch Communication System connected to an unintended LVAS. This communication is to bring awareness and emphasize existing Instructions for Use.
Medical Device Correction: Gallant, Neutrino NxT, and Entrant ICDs and CRT-Ds — August 2023
An urgent Medical Device Correction was issued to inform customers of a rare potential for a Bluetooth (BLE) circuit component issue on a subset of Gallant, Neutrino NxT, and Entrant Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured prior to April 2022.
Important Information Regarding SVD in Trifecta Family of Valves — July, 2023
This communication is to inform customers that Abbott has discontinued its Trifecta family of valves and is initiating inventory-related activities in accordance with respective regulatory frameworks. An example of the communication is below. The exact communication format varies based on region. Additional educational information on long term care and SVD for patients implanted with Trifecta family of valves is available here.
Product Advisory Archive
Medical Device Field Safety Notice: Amplatzer Steerable Delivery Sheath — June 2023
A field safety notice was issued in June 2023 due to the potential for air embolism specific to the hemostasis valve of the Amplatzer™ Steerable Delivery Sheath.
Medical Device Field Safety Notices: CardioMEMS HF System — February 2023
Medical Device Field Safety Notices: CardioMEMS HF System — February 2023
Abbott is notifying clinicians of two issues with the CardioMEMS™ HF System and providing additional instructions to supplement the Instructions for Use. Select CardioMEMS PA Sensors may operate outside of the intended radiofrequency range at higher elevations, and the radiated radiofrequency emissions of CardioMEMS Hospital and Patient Electronics Systems exceed certain emissions limits set by the voluntary CISPR standards. This communication is to bring awareness, share the actions Abbott is taking, emphasize existing Instructions for Use and to provide important additional instructions to supplement the Instructions For Use.
No increase in patient harm or adverse events have been reported as a result of these issues, and it is safe to continue using these devices.
Affected devices vary based on commercial availability in each region. Please find the below clinician and patient communication documents for both issues.
Important Information: Regarding SVD in Trifecta Family of Valves — February 2023
Important Information: Regarding SVD in Trifecta Family of Valves — February 2023
Abbott is providing information regarding Structural Valve Deterioration (SVD) related to the Trifecta family of bioprosthetic heart valves. This communication is intended to raise awareness regarding the potential for early SVD and provide patient management considerations.
Medical Device Correction: MitraClip and TriClip Delivery System(s) – September, 2022
Abbott is sharing information about the use of the MitraClip and TriClip Delivery System(s). Abbott has observed an increase in complaints regarding Clip locking malfunctions. This communication is to bring awareness, share the actions Abbott is taking, and emphasize the relevant steps of the Instructions for Use (IFU) to aid in optimal function of the Clip locking mechanism.
Safety Notification: Zenex, Assurity, and Endurity Pacemakers – Pacemaker Laser Adhesion (July 2022)
An updated Safety Notification was issued in November 2022 to follow-up on the July 2022 notification for a subset of Zenex, Assurity, and Endurity pacemakers.
ASIA PACIFIC
EUROPE
In July 2022, Abbott provided a Safety Notification for a subset of Zenex, Assurity, and Endurity pacemakers that may have an issue with device-to-header adhesion connected to a manufacturing process. This specific manufacturing process is no longer in use.
Affected devices vary based on commercial availability in each region
EUROPE
Medical Device Correction: Merlin Patient Care System (PCS) Software, Merlin 2 Software, and Merlin.net – June 2022
Abbott is notifying customers of the potential for programmer software (Merlin™ PCS Model 3330 v25.3.X or earlier and Merlin™ 2 PCS MER3400 v1.1.2 or earlier) and remote monitoring software applications (Merlin.net™ MN5000 v11.7) to display overestimated predicted battery longevity for certain pacemakers. Pacemaker/battery functionality, therapy delivery, and longevity remain normal and within specifications. Voltage measurements and ERI (elective replacement indicator), which is based on direct voltage measurement, remain accurate. Abbott has developed a software update to improve accuracy of predicted battery longevity. Remote monitoring (Merlin.net) and programmer software updates are targeted to begin June 2022 based on geography.
ASIA PACIFIC
EUROPE
Medical Device Field Safety Notice: Merlin Patient Care System (PCS) Software and Merlin 2 Software – March 2022
Physicians were notified of a programmer software anomaly that may be encountered in a very specific circumstance when executing a pacing capture Decrement Test in-clinic on a Gallant™, Neutrino™ NxT, or Entrant™ device using a Merlin or Merlin 2 Patient Care System (PCS) programmer (based on availability in select markets).
We have developed updated Merlin and Merlin 2 PCS software (Model 3330 v25.0.X-v25.3.X and Model MER3400 v1.1.X-v1.3.X) which corrects this issue. Your Abbott Representative will upgrade your programmer software. Letter distribution and content may vary based on software availability timeframe per region.
ASIA PACIFIC
Urgent Field Safety Notice: Amplatzer Steerable Delivery Sheath, 14F – November 9, 2021
An urgent field safety notice was issued on November 9, 2021, communicating instructions to reduce the potential for air ingress that may occur with the Amplatzer™ Steerable Delivery Sheath hemostasis valve.
Medical Device Correction: HeartMate Touch Communication System – October 22, 2021
An urgent Medical Device Correction was issued on October 22, 2021, communicating that the HeartMate Touch™ Communication System Application is unexpectedly closing or failing to open.
AMERICAS
Safety Notification Update: Subset of Assurity and Endurity Pacemakers – Pacemaker Header (March/October 2021)
An update was issued to the previously communicated Safety Notification for a subset of Assurity™ and Endurity™ pacemakers. Based on further investigation of reported events, Abbott is expanding the safety notification to include additional devices.
EUROPE
On March 15, 2021, we provided a Safety Notification for a subset of Assurity and Endurity pacemakers regarding a low observed rate of malfunctions caused by moisture ingress at the device header.
EUROPE
Urgent Field Safety Notice: Merlin Patient Care System (PCS) Communication - May 12, 2020
We provided an Urgent Field Safety Notice to customers communicating that Merlin PCS V25.0.2 rev 3 programmer software contains an anomaly causing ventricular automatic capture threshold trending configuration values to not properly be communicated and stored in the Gallant family of high-voltage devices including ICDs and CRT-Ds. When this occurs, reported automatic capture thresholds may be falsely elevated, however, the algorithm functions to provide pacing outputs that will always be greater than the reported automatic capture threshold in order to ensure capture. Please find the communication below for further information.
Important Medical Device Correction: Ellipse Implantable Cardioverter Defibrillator (ICD) RF Communication – January 22, 2020
We provided an Important Medical Device Correction notice to customers communicating that a small number of Ellipse™ devices may lose wireless radiofrequency (RF) communication following a recent device software update. Please find the below communication document for further information.
Important Medical Device Recall: HeartMate 3 Modular Cables with LVAS Controller Important Information – December 20, 2019
We provided an Important Medical Device Advisory notice to customers regarding incorrect insertion of the HeartMate 3™ modular cable into the HeartMate 3 Left Ventricular Assist System controller. Please find the below physician communication document for further information.
Urgent Medical Device Recall: HeartMate Mobile Power Unit with HeartMate 3 LVAS Important Information – December 2, 2019
We provided an Urgent Medical Device Recall notice to customers regarding inference of static electricity with the HeartMate Mobile Power Unit™ when used with HeartMate 3 Left Ventricular Assist System. Please find the below physician communication document for further information.
Important Field Safety Notice: CentriMag Acute Circulatory Support System Important Information Line Communication - August 22, 2019
We provided an Important Field Safety Notice to customers communicating that we have received reports of CentriMag™ Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI). Please find the below physician communication document for further information.
Field Safety Notice: Ellipse Implantable Cardioverter Defibrillator (ICD) – Latent Electronics Vulnerability - June 20, 2019
We initiated a Field Safety Corrective Action and subsequently provided an Field Safety Notice to customers. This notice communicated patient management recommendations for a small number of Ellipse implantable cardioverter defibrillators which may be subject to a latent vulnerability in the electronics circuitry. Please find the below physician communication document for further information.
Important Field Safety Notice: CentriMag Acute Circulatory Support System Important Information – September 5, 2018
We provided an Important Field Safety Notice to customers communicating that we have received reports where damage to the cable that connects the motor to the console resulted in interruption of active support. This communication is to remind our physician and hospital partners of the importance of following the proper method for exchanging the CentriMag Acute Circulatory Support System Motor (Model# 201-10002) in the event the system experiences an interruption of power.
Urgent Medical Device Recall: CardioMEMS Hospital and Patient Electronics System Important Information – June 14, 2018
Abbott provided an Urgent Medical Device Recall notice to hospitals, clinics and patients communicating that a small number of CardioMEMS™ Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a false Error 5 message due to an incorrectly configured component within the device electronics. Please find the below patient and hospital communication documents for further information.
Important Medical Device Advisory: HeartMate 3 Left Ventricular Assist System Important Information – May 28, 2018
On May 28, 2018, we provided an update to the Important Medical Device Advisory to physicians regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.
On April 5, 2018, we provided an Important Medical Device Advisory to physicians regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.
Medical Device Advisory: Implantable Cardioverter Defibrillator Cybersecurity Firmware Update – April 23, 2018
We recently notified physicians about the availability of new device firmware to further strengthen the security and improve the performance of our high voltage (HV) implantable cardiac devices (ICDs and CRT-Ds). The firmware upgrade includes improved cybersecurity protection and an update to provide device based premature battery depletion detection in certain HV devices.
Medical Device Advisory: Premature Battery Depletion with Implantable Cardioverter Defibrillator - April 23, 2018
We recently notified physicians about the availability of new device firmware to further strengthen the security and improve the performance of our high voltage (HV) implantable cardiac devices (ICDs and CRT-Ds).
As communicated in August 2017, the BPA algorithm is a management tool and is intended to provide earlier notification of abnormal battery performance for Battery Advisory Devices prior to premature battery depletion. Until now, detection of this alert has only been available through the Merlin.net remote monitoring system and the Merlin programmer during routine follow-up evaluations. This firmware upgrade now allows for device-based detection of abnormal battery performance and if BPA is triggered, a vibratory notification is delivered to the patient, thereby ensuring continuous monitoring in situations where adherence to transmission schedules is challenging (e.g. travel). Additionally, an alert will still continue to be provided to physicians through the Merlin.net remote monitoring system and the Merlin programmer during subsequent follow-up.
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August 29, 2017 – As part of our commitment to continuous improvement, we have recently released an update intended to provide physicians with earlier warning of the potential for premature battery depletion due to short circuits from lithium clusters in patients’ implantable defibrillators.
The new Battery Performance Alert, which can be used as a patient management tool and is intended to help identify potential premature battery depletion in the following devices subject to the October 11, 2016 Medical Device Advisory: Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, and Unify Quadra™.
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On October 10, 2016, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the St. Jude Medical ICD and CRT-D devices manufactured before May 23, 2015 for models Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra:
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Patient Communication
April 16, 2018 Update – Abbott has developed online information for patients, located here. The page includes important information about the new Battery Performance Alert update and responses to frequently asked questions. Patients can also look up their serial numbers for their devices and learn more about remote monitoring options.
Urgent Field Safety Notice: Nanostim Leadless Cardiac Pacemaker Field Safety Notice – April 5, 2018
We provided an update regarding the investigation of the Nanostim™ Leadless Cardiac Pacemaker (LCP) detached docking button.
On November 17, 2017, Abbott provided an Urgent Field Safety Notice to physicians regarding the Nanostim Leadless Cardiac Pacemaker.
Pacemaker Cybersecurity Firmware Update – August 29, 2017
We provided an update to physicians with information on a pacemaker firmware update for Abbott pacemaker models which include the RF telemetry versions of the following devices Outside of the U.S.: Accent SR RF™, Accent ST™, Accent MRI™, Accent ST MRI™, Assurity, Assurity +™, Assurity MRI™, Accent DR RF™, Anthem RF™, Allure RF™, Allure Quadra RF™, Quadra Allure MP RF™, Quadra Allure™, and Quadra Allure MP™.
Patient Communication
Abbott has developed online information for patients, located here. The page includes important information about the update and responses to frequently asked questions from patients.
Medical Device Advisory: Nanostim Leadless Cardiac Pacemaker Important Information – October 28, 2016
We provided an Important Medical Device Advisory to physicians regarding the Nanostim Leadless Cardiac Pacemaker:
Riata and Riata ST Silicone Defibrillation Leads Information
Find information about Riata™ and Riata ST silicone defibrillation leads.
Medical Device Advisory: Optisure Dual Coil HV Leads Important Information – November 2, 2015
On November 2, 2015, we provided an Important Medical Device Advisory to physicians regarding the Optisure™ Dual Coil HV Leads:
On November 4, 2015, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the Optisure Dual Coil HV Leads:
On November 5, 2015, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the Optisure Dual Coil HV Leads:
On November 6, 2015, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the Optisure Dual Coil HV Leads:
Medical Device Advisory: Ellipse and Ellipse ST VR/DR ICD Important Information – August 19, 2014
We provided an Important Medical Device Advisory to physicians regarding the Ellipse and Ellipse ST VR/DR Implantable Cardioverter Defibrillators (ICDs).
Amplatzer Septal Occluder Important Information – For Canadian Residents - April 9, 2014
Health care professional notification | Soins de santé notification professionnel
This letter is to inform physicians about important information concerning the risk of erosion associated with the Amplatzer Septal Occluder.
Cette lettre est d'informer les médecins sur des informations importantes concernant le risque d'érosion associé au dispositif d'occlusion septal Amplatzer.
Public Notification | Avis Public
This letter is to inform the public about important information concerning the risk of erosion associated with the Amplatzer™ Septal Occluder.
Cette lettre est d'informer le public sur des informations importantes concernant le risque d'érosion associé au dispositif d'occlusion septal Amplatzer™.
Field Safety Notice: Accent SR and Accent DR Pacemakers Important Information – April 19, 2013
Accent SR Model PM1110 and Accent DR Model 2112 Pacemakers. Resolution of the potential for the inability to provide rate responsive sensor driven pacing rates:
St. Jude Medical Accent SR Model PM1110 and Accent DR Model 2112 Pacemakers. Potential for the inability to provide rate responsive sensor driven pacing rates:
Field Safety Notice: Fortify ST ICDS Important Information – April 18, 2013
Information on Device Software Upgrade Procedure for Fortify ST ICD Models CD1235-40, CD1235-40Q, CD2235-40, CD2235-40Q:
Medical Device Advisory: QuickSite and QuickFlex LV CRT Leads Important Information – April 4, 2012
We provided a Medical Device Advisory and Important Product Information Update to physicians regarding the QuickSite™ and QuickFlex™ LV CRT leads:
Commitment to Quality
Abbott has a strong history of product safety and reliability, and we remain dedicated to developing technology and products that save and improve the lives of patients worldwide.
We take our responsibilities as a leading manufacturer of cardiac rhythm management devices very seriously and recognize our primary responsibility as a global medical device manufacturer is to ensure that our devices are of the highest quality and function safely and properly.
Product Performance
As part of our commitment to quality, we keep medical professionals and their patients informed on the performance of our devices. St. Jude Medical releases a semi-annual report detailing overall performance and reliability of its Cardiac Rhythm Management products.
Current and Archived Product Performance Reports
QuickFlex µ and Quartet Optim Insulated Leads are Not Included in this Advisory
QuickFlex µ and Quartet™ Optim™ insulated LV CRT leads have demonstrated superior performance during the approximately three years they have been on the market. There have been zero reports of externalized conductors in QuickFlex µ and Quartet Optim LV CRT leads, and they continue to demonstrate excellent performance by any measure.
All QuickFlex µ and Quartet Optim insulated LV CRT leads are constructed with full-body Optim insulation, a material shown to be 50 times more abrasion resistant than silicone insulation.1
View product information for QuickFlex µandQuartet Optim™ leads.
Epic and Atlas ICDs Important Information – January 16, 2008
Important Device Upgrade Information – Epic™ & Atlas™ Family of ICDs
We are making a programmer software upgrade available to resolve and eliminate a very rare occurrence (incidence of 8 in 143,000 devices) that could lead to a ventricular sensing anomaly in our Epic™ and Atlas™ families of Implantable Cardioverter Defibrillators (ICDs). The new programmer software (version 6.4.1 for MerlinPCS and version 6.5.1 for Model 3510) will allow a programmer to automatically identify a device that can benefit from a firmware upgrade to resolve and eliminate the potential issue with a simple, one time device software upgrade.
St. Jude Medical Field Sales Staff and Field Clinical Engineers will install this software upgrade in Merlin PCS and Model 3510 programmers in the field. Thereafter, upon initial interrogation of an Epic or Atlas family ICD, the Merlin or 3510 programmer will automatically identify implanted devices that require a firmware upgrade and will inform the clinician with a message that an upgrade should be performed. The programmer will complete the device upgrade in approximately 10-20 seconds. During the upgrade process the device continues to function as programmed, with all bradycardia and tachycardia functions fully available.
Approximately 143,000 Epic and Atlas family ICDs have been implanted worldwide since July 2002; approximately 123,000 of these devices remain in service. To date, 8 out of 143,000 of the subject device population (an incidence of 0.00006) have been found to exhibit a loss of ventricular sensing, with a risk of patient harm estimated to be on the order of 1 in 1 million (0.000001).
The loss of ventricular sensing has been attributed to a well defined, yet extremely rare timing sequence that occurs in a very small (61 microsecond) timing window. No patient injuries or deaths have been reported to St. Jude Medical as the result of a device entering the described loss of sensing state. As mentioned above, the potential issue can be fully resolved and eliminated by a programmer initiated upgrade to the device.
In Summary:
A simple programmer software/device firmware upgrade will resolve the issue and prevent a future occurrence. Patients who are followed on a routine basis with scheduled follow-up visits every three to six months should continue with their scheduled visit. Upon interrogation of one of the subject devices, the Merlin and Model 3510 programmers with the newly provided software will automatically identify a device that can benefit from a firmware upgrade and will instruct the clinician that an upgrade is available.
We, along with our independent Medical Advisory board members have determined that no other action is recommended.
REFERENCES
1. Jenney, C., Tan, J. Karicherla, A., Burke, J., & Helland, J. (2005) A new insulation material for cardiac leads with potential for improved performance. Heart Rhythm, 2(Suppl. 5), S318-S319. https://dx.doi.org/10.1016/j.hrthm.2005.02.1004
MAT-1901531 v39.0