Medical DeviceJun 24, 2026
HeartMate 3" System Controller recall — FDA Z-2519-2026
Due to 11 volt Backup Battery failures.
Class IIFDA: OngoingThoratec LLC
Recall history in this database
Classification mix: Class II: 9, Class I: 3.
Medical DeviceJun 24, 2026
HeartMate 3 Left Ventricular System (LVAS) Kits recall — FDA Z-2518-2026
Due to 11 volt Backup Battery failures.
Class IIFDA: OngoingThoratec LLC
Medical DeviceJun 24, 2026
HeartMate HM 11V Li-ion Backup Battery, ABT recall — FDA Z-2520-2026
Due to 11 volt Backup Battery failures.
Class IIFDA: OngoingThoratec LLC
Medical DeviceJan 21, 2026
Thoratec CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016 recall — FDA Z-1099-2026
Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to…
Class IIFDA: OngoingThoratec LLC
Medical DeviceNov 26, 2025
HeartMate 3 Controller (Standalone) recall — FDA Z-0506-2026
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Class IIFDA: OngoingThoratec LLC
Medical DeviceNov 26, 2025
HeartMate II Controller (standalone) recall — FDA Z-0508-2026
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Class IIFDA: OngoingThoratec LLC
Medical DeviceNov 26, 2025
HeartMate II LVAS Implant Kit recall — FDA Z-0507-2026
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Class IIFDA: OngoingThoratec LLC
Medical DeviceNov 26, 2025
HeartMate 3 Left Ventricular System (LVAS) Kits recall — FDA Z-0505-2026
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Class IIFDA: OngoingThoratec LLC
Medical DeviceAug 20, 2025
HeartMate Mobile Power Unit, AC Power Cord recall — FDA Z-2290-2025
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…
Class IFDA: OngoingThoratec LLC
Medical DeviceAug 20, 2025
HeartMate Mobile Power Unit recall — FDA Z-2291-2025
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…
Class IFDA: OngoingThoratec LLC
Medical DeviceApr 23, 2025
Thoratec HeartMate Mobile Power Unit: REF: 107754, NA recall — FDA Z-1570-2025
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…
Class IFDA: OngoingThoratec LLC
Medical DeviceAug 21, 2024
Thoratec HeartMate 3 System Controllers provided within the following HeartMate 3 Left recall — FDA Z-2583-2024
Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage…
Class IIFDA: OngoingThoratec LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies Thoratec LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.