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 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.

Product Information Letter: HeartMate 3 Electrostatic Discharge Awareness — July 2024

Abbott notified customers about air fluidized specialty beds as a potential source of static electricity and the possible impact on functionality of the HeartMate 3™ LVAS. This letter enhances information already in the Instructions for Use. Alternatives to air fluidized specialty beds should be considered when using the HeartMate 3 LVAS.

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.

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 there monitor screen issues are observed. The System Monitor is not being removed from the field and does not need to be returned to Abbott.

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 prior to February 2024. This issue is corrected through a firmware upgrade.

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.

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.

Medical Device Correction: HeartMate Touch Communication System – January 2024

An urgent Medical Device Correction 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 Ventricle Asist Device (LVAD)

Medical Device Field Safety Notices: CardioMEMS Patient Electronics System — October 2023

Abbott is notifying patients and clinicians 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.

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.

The specific impacted serial numbers are listed on the links below. Please review Appendix A as of August 2023, Appendix A Expanded Scope as of September 2023, and Appendix A Expanded Scope as of October 2023 for the specific serial numbers within the scope of this notification.

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.

Medical Device Recall: Amplatzer Steerable Delivery Sheath — June 2023

A recall notification was issued to customers in June 2023 due to the potential for air embolism specific to the hemostasis valve of the Amplatzer™ Steerable Delivery Sheath.

Medical Device Correction: CardioMEMS HF System — February 2023

Abbott is notifying clinicians of two issues with the CardioMEMS™ HF System and providing important 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 (Model CM3000) and Patient Electronics Systems exceed certain emissions limits set by the voluntary CISPR standard. This communication is to bring awareness, share the actions that 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.

Abbott is notifying patients related to the CardioMEMS Patient Electronics Systems exceeding certain emissions limits set by the voluntary CISPR standard. This communication is to bring awareness and emphasize existing Instructions for Use as well as providing additional supplemental instruction.

No patient harm or adverse events have been reported as a result of this issue, and it is safe to continue using these devices.

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 Delivery System — September, 2022

Abbott is sharing information about the use of the MitraClip Delivery System. 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.

Medical Device Correction: Merlin Patient Care System (PCS) Software and Merlin.net – June 2022

Abbott is notifying customers of the potential for programmer software (Merlin™ PCS Model 3330 v26.0.1 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 MN5000 v11.7) and programmer software updates are targeted to begin June 2022.

Medical Device Correction: Merlin Patient Care System (PCS) 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™ or Entrant™ device using a Merlin Patient Care System (PCS) programmer. We have developed updated Merlin PCS software (Model 3330 v25.0.X-v25.3.X) which corrects this issue. Your Abbott Representative will upgrade your programmer software beginning in March 2022.

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 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.

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.

Medical Device Correction: Merlin Patient Care System (PCS) - February 28, 2020

An important medical device correction notice communicating that Merlin PCS V24.6.1 contains an anomaly that may result in specific programming changes not being stored in the device. We have proactively reviewed 100% of patient records and confirmed there is no impact to patients, and no intervention is needed.

Voluntary Recall: Specific Lots of Coronary Catheters - January 29, 2020

A field safety notice (FSN) was issued on Jan. 29, 2020, to physicians and hospitals who received coronary-specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm and 5.0mm.

Medical Device Correction: Ellipse Implantable Cardioverter Defibrillator (ICD) Radio Frequency - January 22, 2020

An important medical device correction notice communicating that a small number of Ellipse™ devices may lose wireless radiofrequency (RF) communication following a recent device software update.

Urgent Medical Device Correction: Confirm Rx ICM Inability to Pair the Implanted Device – November 2018

An urgent medical device correction notice communicating a voluntary recall of a small number of Confirm Rx™ Insertable Cardiac Monitors (ICM) subject to a communication issue resulting in the inability to pair the implanted device with the mobile phone app.

Urgent Medical Device Recall: CentriMag Acute Circulatory Support System - August 22, 2019

An urgent medical device recall notice to customers communicating that we have received reports of CentriMag™ Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).

Urgent Medical Device Recall: Ellipse Implantable Cardioverter Defibrillator (ICD) Latent Electronics Vulnerability – June 20, 2019

A product recall and a subsequently provided urgent medical device recall notice communicating patient management recommendations for a small number of Ellipse implantable cardioverter defibrillators which may be subject to a latent vulnerability in the electronics circuitry.

Urgent Medical Device Recall: HeartMate 3 Outflow Graft Leak (C-Ring) – March 30, 2019

An urgent medical device recall notice communicating reports of the HeartMate 3 Outflow Graft leaking at its pump connection during implantation because the Screw Ring either disconnected or did not tighten completely. The information below includes patient management recommendations.

Urgent Medical Device Recall: HeartMate Coring Tool with Black Particle From Blade Cover – March 7, 2019

An urgent medical device recall notice communicating that a physician observed a small black plastic particle in the left ventricle during the implant procedure after using the HeartMate 3 Coring Tool. Investigation into this issue has confirmed that the particle came from the Coring Tool’s plastic blade cover.

Product Advisory Archive

Urgent Medical Device Recall: HeartMate Mobile Power Unit with HeartMate 3 LVAS - December 2, 2019

An urgent medical device recall notice regarding interference of static electricity with the HeartMate Mobile Power Unit™ when used with HeartMate 3™ Left Ventricular Assist System.

Urgent Medical Device Recall: HeartMate 3 Left Ventricular Assist System – October 17, 2018

An update to the previously communicated Class I Recall associated with the HeartMate 3 Left Ventricular Assist System. We have received FDA approval for the Outflow Graft Clip, designed to prevent any rotation of the outflow graft, thus addressing the safety concern reported in the May 2018 notice. The Outflow Graft Clip is now available.

On May 22, 2018, the FDA classified this medical device advisory as a Class I Recall. We provided a frequently asked questions document for physician use as needed, to cover the most common questions relating to the HeartMate 3 Left Ventricular Assist System recall.

On May 21, 2018, we provided an update to the important medical device advisory 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 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.

Urgent Medical Device Recall: CentriMag Acute Circulatory Support System – September 5, 2018

An urgent medical device recall 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 102956 in the event the system experiences an interruption of power.

Urgent Medical Device Recall: CardioMEMS Hospital and Patient Electronics System – June 14, 2018

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.

Urgent Medical Device Correction: Confirm Rx ICM with Incorrect Low Battery Indicators Due to Cold Temperature – May 18, 2018

We notified physicians that exposure to sub-freezing temperatures during our supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Insertable Cardiac Monitoring (ICM) Model DM3500 devices. Updated Merlin programmer software will be made available to allow physicians to detect the presence of an incorrect low battery indicator prior to implant and provide a mechanism to resolve the incorrect display for already implanted devices.

On April 16, 2018, we 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 16, 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 Battery Performance Alert (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.

On April 16, 2018, we developed online information for patients. This 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.

On 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™ pacemakers and CRT-P devices.

Medical Device Information: Nanostim Leadless II IDE/CAP Study – April 5, 2018

On April 5, 2018, we provided an update regarding the investigation of the Nanostim™ Leadless Cardiac Pacemaker Study (LCP) detached docking button.

On November 17, 2017, we provided a communication to physicians regarding the Nanostim Leadless Cardiac Pacemaker.

Safety Notice: Pacemaker Cybersecurity Firmware Update – August 29, 2017

November 22, 2019 – Abbott recently completed an analysis of over 400,000 patient device cybersecurity firmware updates. This real-world data set provides an update to the risk profile associated with executing cybersecurity firmware updates.

On August 29, 2017, Abbott 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 in the U.S.: Accent SR RF™, Accent MRI™, Assurity, Assurity MRI™, Accent DR RF™, Anthem RF™, Allure RF™, Allure Quadra RF™ and Quadra Allure MP RF™.

Watch the low voltage device firmware cybersecurity update – this video will review the steps to update the device firmware.

Abbott has developed online information for patients. This page includes important information about the update and responses to frequently asked questions from patients.

Medical Device Information: Nanostim Leadless II IDE/CAP Study – October 28, 2016

On October 28, 2016, we provided an important medical device information communication to physicians regarding the Nanostim Leadless II IDE/CAP Study.

Medical Device Advisory: Optisure Dual Coil HV Leads – November 3, 2015

On January 22, 2016, we provided an important medical device advisory update regarding the Optisure™ Dual Coil HV Leads.

On November 3, 2015, we provided an important medical device advisory regarding the Optisure Dual Coil HV Leads.

Considerations: Older Generation Pacemakers – January 29, 2014

Considerations When Using Electrocautery in Patients Implanted with Older Generation St. Jude Medical™ Pacemakers (Affinity™, Entity™, Integrity™, Identity™, Sustain™, Frontier™, Victory™ and Zephyr™ models).

Medical Device Advisory: Ellipse and Ellipse ST VR/DR ICD – August 19, 2014

On August 19, 2014, we provided an important medical device advisory regarding the Ellipse™ and Ellipse™ ST VR/DR Implantable Cardioverter Defibrillators (ICDs).

Medical Device Correction: Merlin@home RF Remove Monitoring Transmitter – December 18, 2014

On December 18, 2014, we provided an important medical device correction to physicians regarding the Merlin@home™ RF Remote Monitoring Transmitter Model EX1150.

On August 18, 2015, we provided an important medical device correction update regarding the Merlin@home RF Monitoring Transmitter Model EX1150.

Medical Device Advisory: QuickSite and QuickFlex LV CRT Leads – April 4, 2012

On April 3, 2012, we provided a medical device advisory and important product information update regarding the QuickSite™ and QuickFlex™ LV CRT leads.

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

Important Information: Amplatzer Septal Occluder (ASO) – May 24, 2012

AMPLATZER Septal Occluder (ASO) FDA Panel Review Materials

The FDA occasionally invites medical manufacturers to review device performance in a public forum to determine if any changes are needed for device labeling or whether any additional data needs to be collected to better understand device performance. St. Jude Medical was invited to the Circulatory System Devices Panel of the Medical Devices Advisory Committee for discussion on May 24, 2012.

Supporting Materials

Supporting documents for the FDA panel provided by St. Jude Medical include:

The American College of Cardiology (ACC) guidelines focus on assisting healthcare providers in clinical decision making, defining practices that meet the needs of most patients in most circumstances and supporting the practicing cardiologist in the care of adult congenital heart disease (ACHD) patients:

The ACC guidelines focus on assisting healthcare providers in clinical decision making, defining practices that meet the needs of most patients in most circumstances and supporting the practicing cardiologist in the care of pediatric patients with congenital heart disease.

The AMPLATZER™ Septal Occluder Delivery System Instructions for Use (IFU) was updated in January 2012.

AMPLATZER Septal Occluder (ASO) Instructions For Use Updates

This letter is to inform physicians about important information concerning the AMPLATZER Septal Occluder instructions for use.

Product Performance Information: Riata and Riata ST Silicone Defibrillation Leads

We voluntarily and proactively stopped selling our Riata™ and Riata ST Silicone Defibrillation Leads in December 2010. Find more information here.

 

Important Device Upgrade Information: Epic and Atlas ICDs – January 16, 2008

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

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