Product Advisories

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 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.

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)

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.

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

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

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

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

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.

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.

Product Advisory Archive

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.

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 Rhythm2(Suppl. 5), S318-S319. https://dx.doi.org/10.1016/j.hrthm.2005.02.1004

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