Safety Alerts
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 […]