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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
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