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.

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 […]

Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures

Boston Scientific is recalling the EMBLEM S-ICD Subcutaneous Electrode because of increased risk of fractures at a specific point (distal to the proximal sense ring). […]