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Safety Alerts
Safety Notice Regarding Medtronic ICDs and CRT-Ds
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…
May 10, 2023
Safety Alerts
Merlin Patient Care System (PCS) Programmer and Merlin 2 PCS Programmer When Used with Gallant, Neutrino NxT, or Entrant Devices
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,…
March 23, 2023
Safety Alerts
Update to Safety Notice for Subset of Zenex, Assurity and Endurity Pacemakers
Abbott recently isssued a follow up to the July 2022 Field Safety Notice affecting a specific subset of Zenex™, Assurity™, and Endurity™ pacemakers.
December 21, 2022
Safety Alerts
Abbott Zenex™, Assurity™, and Endurity™ Pacemakers Manufactured Outside the U.S.
Abbott is notifying clinicians of the potential for device malfunction which may impact a specific subset of pacemakers of Zenex™, Assurity™, and Endurity™ families.
August 12, 2022
Safety Alerts
Safety Notice Regarding Medtronic Cobalt XT, Cobalt, and Crome ICDs and CRT-Ds
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)…
June 23, 2022
Safety Alerts
Merlin Programmer Software and Merlin.net Remote Monitoring Application in the Accent/Anthem and Endurity/Assurity/Allure Family
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.
June 21, 2022
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
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