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.

Update to 2021 Advisory Regarding Certain Boston Scientific Pacemakers with Potential for Entering Safety Mode with Inhibition of Pacing

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

December 14, 2023 – Boston Scientific has issued an update to their 2021 advisory regarding the potential for high battery impedance in INGENIO™, VITALIO™, and ADVANTIO™ dual chamber (DR) extended life (EL) pacemakers and INLIVEN™, INTUA™, and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-Ps).

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

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

May 10, 2023 - Medtronic has distributed notification regarding the potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) (manufactured after July 2017) with a specific (glassed) feedthrough, including ICDs and CRT-Ds that are currently available for new implantation.

Update to Safety Notice for Subset of Zenex, Assurity and Endurity Pacemakers

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

December 21, 2022 - Abbott recently isssued a follow up to the July 2022 Field Safety Notice affecting a specific subset of ZenexTM, AssurityTM, and EndurityTM pacemakers. The issue stemmed from an intermittent manufacturing laser surface preparation subprocess at the device header joint potentially leading to moisture ingress.

HRS' interpretation of this update: This failure mechanism appears unlikely to occur before 1.44 years (from time of implant), so that early failures are unlikely; however, lack of early failure is not predictive of long-term device integrity.

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.

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