Class IIOngoingZ-2520-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery
Due to 11 volt Backup Battery failures.
Thoratec LLCCAJun 24, 2026
Ventricular (Assist) Bypass recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–11 of 11 recalls
Class IIOngoingZ-2519-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Numb…
Due to 11 volt Backup Battery failures.
Thoratec LLCCAJun 24, 2026
Class IIOngoingZ-2518-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits M…
Due to 11 volt Backup Battery failures.
Thoratec LLCCAJun 24, 2026
Class IIOngoingZ-2320-2026
BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
BERLIN HEART GMBHJun 17, 2026
Class IIOngoingZ-0508-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catal…
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Thoratec LLCCANov 26, 2025
Class IIOngoingZ-0507-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Numb…
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Thoratec LLCCANov 26, 2025
Class IIOngoingZ-0506-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog…
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Thoratec LLCCANov 26, 2025
Class IIOngoingZ-0505-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits M…
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Thoratec LLCCANov 26, 2025
Class IOngoingZ-2291-2025
Thoratec LLC recalls Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 S…
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Thoratec LLCCAAug 20, 2025
Class IOngoingZ-2290-2025
Thoratec LLC recalls Brand Name: HeartMate Product Name: Mobile Power Unit
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Thoratec LLCCAAug 20, 2025
Class IOngoingZ-1570-2025
Thoratec LLC recalls HeartMate Mobile Power Unit: REF: 107754
Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wren…
Thoratec LLCCAApr 23, 2025