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Safety Alerts
Biosense Webster Advisory: Update to the Instructions for Use for VARIPULSE
On February 14, 2025, Biosense Webster, Inc. (BWI) initiated a device correction notification to inform practitioners of updates to the Instructions for Use (IFU) for…
March 26, 2025
Safety Alerts
Abbott Advisory: Manufacturing Defect Associated with Loss of Pacing for a Limited Subset of Assurity™ and Endurity™ Pacemakers
Abbott is informing clinicians of the potential for device malfunction due to a manufacturing concern which may affect a limited subset of Assurity™ and Endurity™…
February 18, 2025
Safety Alerts
Philips Urgent Medical Device Correction: Mobile Cardiac Telemetry (MCT) or Event Diagnostic Service Processing
Philips has issued an urgent medical device correction impacting its MCT or Event Diagnostic Service utilizing the Philips MCT during the period of July 2022-July…
February 5, 2025
Safety Alerts
Boston Scientific Advisory: Subset of Pacemakers Exhibit High Battery Impedance Initiating Safety Mode
Boston Scientific has identified a subpopulation of dual chamber, standard life and extended life pacemakers; cardiac resynchronization therapy pacemakers (CRT-Ps) with an increased potential to…
December 17, 2024
Safety Alerts
Merlin Patient Care System Software Anomaly When Used with AVEIR DR Leadless System
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.
December 12, 2024
Safety Alerts
Boston Scientific Advisory: Cardiac Cryoablation System
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…
October 15, 2024
Safety Alerts
Abbott Advisory: For a Subset of AVEIR VR Leadless Pacemakers Manufactured Prior to February 1, 2024
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…
April 8, 2024
Safety Alerts
Update to 2021 Advisory Regarding Certain Boston Scientific Pacemakers
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)…
December 14, 2023
Safety Alerts
Abbott Advisory: Manufacturing Defect Associated with Loss of Pacing for a Limited Subset of 455 Assurity™ and Endurity™ Pacemakers
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™…
October 16, 2023
Safety Alerts
Abbott Advisory: Bluetooth Circuit Component Malfunction for Certain ICDs and CRT-Ds Manufactured Prior to April 2022
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…
August 16, 2023