Safety Alerts

Abbott is notifying customers of a programmer software anomaly that may occur during very specific circumstances during finalization of the AVEIR DR Leadless Pacemaker system. This can occur either during an upgrade to a dual chamber system or during a new dual chamber system implant. It does not occur with single chamber leadless device implants.

Boston Scientific is notifying customers about an update to the instructions for use to mitigate the potential for atrio-esophageal (AE) fistula with their cryoballoon ablation system.

Abbott is notifying customers of the potential for an inadvertent mode change to occur in a subset of AVEIR VR LSP 112V devices manufactured prior to February 2024. This mode change leads to increased pacing output and rate, resulting in decreased device longevity.

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).

October 16, 2023 - Abbott is informing clinicians of the potential for device malfunction due to a manufacturing plant malfunction which may affect a limited subset of 455 Assurity™ and Endurity™ pacemakers.

August 16, 2023 - Abbott has notified customers of the rare potential for a Bluetooth circuit component malfunction on a subset of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured prior to April 2022. Download Notice

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.

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.

August 1, 2022 - Abbott is notifying clinicians of the potential for device malfunction which may impact a specific subset of pacemakers of Zenex^TM, Assurity^TM, and Endurity^TM 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.

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.