Safety Alerts

HRS works closely with our industry partners, domestic and global professional societies, and federal regulatory agencies to communicate safety concerns with HRS members.

Use the search engine below to find safety alerts based on the title, year, or device serial number. Filters are not required, but they can improve the search capabilities.

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Abbott Safety Notification Regarding a Subset of Assurity and Endurity Pacemakers

Safety Alerts

U.S. Food and Drug Administration (FDA)

March 19, 2021 - Abbott announced a safety notification that some Assurity and Endurity pacemakers manufactured between 2015 and 2018 have experienced moisture ingress into the header of the pacemaker pulse generator causing a percentage of devices to malfunction. HRS is working together with Abbott and the Food and Drug Administration on this communication to ensure our members have the latest, accurate information.

Medtronic Safety Communication Regarding a Subset of ICDs and CRT-Ds

Regulatory Agencies

Safety Alerts

U.S. Food and Drug Administration (FDA)

February 8, 2021 - Medtronic has issued a follow-up to its Product Performance Note relating to battery performance for a subset of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Defibrillators (CRT-Ds). HRS is working together with Medtronic and the Food and Drug Administration on this communication to ensure our members have the latest information.

Safety Advisories Regarding Boston Scientific Emblem S-ICD

Regulatory Agencies

Safety Alerts

U.S. Food and Drug Administration (FDA)

December 4, 2020 - On December 3, Boston Scientific announced three advisories related to its Emblem S-ICD. They address the potentials for battery depletion, device damage due to electrical shorting, and lead fracture.

Longevity Estimator Software Error for Subset of Medtronic CIEDs

Regulatory Agencies

Safety Alerts

U.S. Food and Drug Administration (FDA)

October 8, 2019 - On October 3, 2019, Medtronic began notifying healthcare professionals that a subset of pacemakers and implantable cardioverter defibrillators (including CRT and Micra TPS devices) manufactured between October 2018 and April 2019 may display an inaccurately short estimate of battery longevity.

Safety Advisory Regarding A Subset of Boston Scientific EMBLEM™ S-ICDs

Regulatory Agencies

Safety Alerts

U.S. Food and Drug Administration (FDA)

August 21, 2019 - Boston Scientific released an Urgent Medical Device Advisory regarding the performance of approximately 400 Model A209/A219 EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillators (S-ICD) worldwide, manufactured in July 2017.

Potential Premature Battery Depletion of Certain Medtronic Implantable Pacemakers and CRT-Ps (Azure, Astra, Percepta, Serena and Solara models)

Regulatory Agencies

Safety Alerts

U.S. Food and Drug Administration (FDA)

May 7, 2019 - The U.S. Food and Drug Administration issued a safety communication to inform patients and health care professionals about the potential for the batteries of certain Medtronic implantable pacemakers to drain more quickly than expected and without warning to patients.

Medtronic Reports Potential Vulnerabilities to Selected Wireless Communication Technologies (Conexus Telemetry and Monitoring Accessories)

Regulatory Agencies

Safety Alerts

March 25, 2019 - Medtronic has identified potential vulnerabilities to wireless technologies (Conexus telemetry) used to monitor certain ICDs, CRT-Ds, and programmers. Medtronic highlights that no cases of cyberattack, privacy breech, or patient harm have been observed or associated with these vulnerabilities.

Subset of Medtronic Pacemakers - Potential Circuit Error

Regulatory Agencies

Safety Alerts

January 22, 2019 - On January 17, 2019, Medtronic issued an urgent voluntary recall and distribution suspension affecting a subset of dual-chamber pacemakers distributed worldwide between March 10, 2017 and January 7, 2019, including the brand names:AdaptaTM, Versa^TM, and Sensia^TM (USA); Relia^TM, Attesta^TM, Sphera^TM, and Vitatron^TM A/E/G/Q series (outside of USA).

Software Update for LifeVest 4000 Wearable Cardioverter Defibrillator

Regulatory Agencies

Safety Alerts

U.S. Food and Drug Administration (FDA)

January 15, 2019 (Update) - The FDA approved a new software for the ZOLL LifeVest 4000 for patient alerts when a “Call for service – Message Code 102” is displayed. The potential hazard of the device failing to deliver treatment to a patient if the device is not replaced soon after displaying a “Call for service – Message Code 102” was previously described in the January 17, 2018 FDA Safety Communication and an update on July 25, 2018.

FDA Safety Communication- ZOLL LiveVest 4000

Safety Alerts

U.S. Food and Drug Administration (FDA)

January 15, 2019 - The FDA approved a new software for the ZOLL LifeVest 4000 for patient alerts when a “Call for service – Message Code 102” is displayed. The potential hazard of the device failing to deliver treatment to a patient if the device is not replaced soon after displaying a “Call for service – Message Code 102” was previously described in the January 17, 2018 FDA Safety Communication and an update on July 25, 2018.