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Safety Alerts
BIOTRONIK Safety Communication Regarding a Subset of ICDs and CRT-Ds
Earlier this month, BIOTRONIK announced a field safety notice that some ICDs and CRT-Ds are exhibiting premature battery depletion.
March 22, 2021
Safety Alerts
Abbott Safety Notification Regarding a Subset of Assurity and Endurity Pacemakers
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…
March 19, 2021
Safety Alerts
Medtronic Safety Communication Regarding a Subset of ICDs and CRT-Ds
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…
February 8, 2021
Safety Alerts
Safety Advisories Regarding Boston Scientific Emblem S-ICD
On December 3, Boston Scientific announced three advisories related to its Emblem S-ICD.
December 4, 2020
Safety Alerts
Longevity Estimator Software Error for Subset of Medtronic CIEDs
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…
October 8, 2019
Safety Alerts
Safety Advisory Regarding A Subset of Boston Scientific EMBLEM™ S-ICDs
n August 21, 2019, Boston Scientific released an Urgent Medical Device Advisory regarding the performance of approximately 400 Model A209/A219 EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillators…
August 21, 2019
Safety Alerts
Potential Premature Battery Depletion of Certain Medtronic Implantable Pacemakers and CRT-Ps
The U.S. Food and Drug Administration issued a safety communication to inform patients and health care professionals about the potential for the batteries of certain…
May 7, 2019
Safety Alerts
Medtronic Reports Potential Vulnerabilities to Selected Wireless Communication Technologies
Medtronic has identified potential vulnerabilities to wireless technologies (Conexus telemetry) used to monitor certain ICDs, CRT-Ds, and programmers.
March 25, 2019
Safety Alerts
Subset of Medtronic Pacemakers – Potential Circuit Error
On January 17, Medtronic issued an urgent voluntary recall and distribution suspension affecting a subset of dual-chamber pacemakers distributed worldwide between March 10, 2017 and…
January 22, 2019
Safety Alerts
FDA Safety Communication- ZOLL LiveVest 4000
The FDA approved a new software for the ZOLL LifeVest 4000 for patient alerts when a “Call for service – Message Code 102” is displayed.
January 15, 2019
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