Class IIOngoingZ-0726-2026
Medtronic, Inc. recalls Aurora EV-ICD and Clinical EV-ICD
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Medtronic, Inc.MNDec 10, 2025
Implantable Cardioverter Defibrillator (Non-Crt) recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–3 of 3 recalls
Class IOngoingZ-0093-2026
Boston Scientific Corporation recalls Model Number L101
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…
Boston Scientific Corp…MNOct 22, 2025
Class IOngoingZ-2325-2025
Boston Scientific Corporation recalls ENDOTAK RELIANCE G/SG
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement.…
Boston Scientific Corp…MNAug 27, 2025