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.

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.

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.