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Safety Alerts
Safety Notice Regarding Subset of Abbott Assurity and Endurity Pacemakers Manufactured Between 2015 and 2018
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…
October 7, 2021
Safety Alerts
Safety Advisories Notice: Medtronic Reveal LINQ with TruRhythm (LNQ11) and LINQ II (LNQ22)
Medtronic has announced a medical device correction for the LINQ and LINQ II insertable cardiac monitors (ICMs).
June 22, 2021
Safety Alerts
Medical Device Advisories Regarding Certain Boston Scientific Pacemakers
Boston Scientific (BSC) recently announced two distinct, unrelated medical device advisories related to certain pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps).
June 21, 2021
Safety Alerts
FDA Issues Communication on CIEDs and Certain Consumer Devices
The U.S. Food and Drug Administration (FDA) issued a communication on potential interactions between certain cell phones and smart watches.
May 13, 2021
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