Safety Alerts | Heart Rhythm Society

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.

Abbott ZenexTM, AssurityTM, and EndurityTM Pacemakers Manufactured Outside the U.S.

Safety Alerts
U.S. Food and Drug Administration (FDA)

August 1, 2022: Abbott is notifying clinicians of the potential for device malfunction which may impact a specific subset of pacemakers of ZenexTM, AssurityTM, and EndurityTM families. The types of malfunctions noted include loss of pacing, reduced battery longevity, devices reverting to back-up mode, and/or loss of telemetry /communication. Up until June 2022, the observed rate has been low at 0.15% and there have been no reports of permanent harm nor deaths. These devices were distributed and implanted in geographies outside the United States.

Safety Notice Regarding Medtronic Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)

Safety Alerts
U.S. Food and Drug Administration (FDA)

June 23, 2022- Medtronic has notified health care professionals of the potential for Intermittent- Reduced-Energy Shock during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

Pacing, sensing, episode detection, and anti-tachycardia pacing (ATP) therapies are not impacted; additionally, HV charging, battery longevity and Bluetooth telemetry are not impacted. This advisory does not apply to other ICD models.

Merlin Programmer Software and Merlin.net Remote Monitoring Application when used with pacemakers in the Accent/Anthem and Endurity/Assurity/Allure family

Safety Alerts
U.S. Food and Drug Administration (FDA)

June 21, 2022 — Abbott has identified the potential for programmer software (MerlinTM PCS) and remote monitoring software applications (Merlin.net) 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 are based on direct voltage measurement, remain accurate. This advisory does not apply to battery estimates for other devices (such as ICDs).

Merlin Patient Care System (PCS) Programmer and Merlin 2 PCS Programmer When Used with Gallant, Neutrino NxT, or Entrant Devices

Safety Alerts
U.S. Food and Drug Administration (FDA)

March 23, 2022 - Abbott has detected a software anomaly in the MerlinTM and MerlinTM 2 Patient Care System (PCS) programmers that have software versions supporting GallantTM, NeutrinoTM NxT, and EntrantTM devices (Software Models 3330 v25.0.X-v25.3.X and MER3400 v1.1.X – v1.3.X). The issue is specific to using the Decrement Test Method (either voltage or pulse width decrement threshold testing) on the programmer to perform a pacing capture threshold test on a Gallant, Neutrino NxT, or Entrant device.

Safety Notice Regarding Subset of Abbott Assurity and Endurity Pacemakers Manufactured Between 2015 and 2018

Safety Alerts
U.S. Food and Drug Administration (FDA)

October 7, 2021 (Update) - On March 15, 2021, Abbott announced a safety notice that some Assurity and Endurity pacemakers manufactured between 2015 and 2018 experienced moisture ingress into the header of the pacemaker pulse generator, causing a small percentage of devices to fail (initially estimated at 0.049% and now roughly at 0.07%).

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

Safety Alerts
U.S. Food and Drug Administration (FDA)

March 22, 2021 - Earlier this month, BIOTRONIK announced a field safety notice that some ICDs and CRT-Ds are exhibiting premature battery depletion. HRS is working together with BIOTRONIK and the Food and Drug Administration on this communication to ensure our members have the latest, most accurate information.

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.