Safety Alerts - LEADconnection - Page 3
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Safety Alerts

The following content includes advisories, recalls, safety alerts, doctor letters, field action letters, product performance reports and other related information.

Safety Notification Update FOR A SUBSET OF ASSURITY™ AND ENDURITY™ PACEMAKERS

A subset of Abbott AssurityTM and EndurityTM pacemakers may be impacted by intermittent incomplete mixing of epoxy in the manufacturing process, allowing moisture into the pulse generator header, introducing a risk of interrupting device functionality

Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Transition to Safety Mode

Boston Scientific is recalling INGENIO family of pacemakers and CRT-Ps due to the risk of transitioning to safety mode. The FDA has identified this as a […]

SmartSync Longevity Estimation Software Error: Percepta MRI, Serena MRI and Solara MRI CRT-P devices

New software is available to correct the longevity estimation error for CareLink SmartSync™ Device Managers

Potential premature battery depletion in a subset of Biotronic ICD and CRT-D devices

There is potential premature battery depletion in a subset of Biotronik ICD and CRT-D devices

Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit

Boston Scientific is recalling the EMBLEM S-ICD because a manufacturing process may allow moisture to get inside the defibrillator and cause a short-circuit when it […]