Thoratec recalls
12 official recalls and safety alerts involving Thoratec since 2021-12, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Thoratec or the relevant agency.
- 2026-06-24
USThoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product…
Due to 11 volt Backup Battery failures.
FDA · DeviceThoratec LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →- 2026-01-21
- US
Thoratec LLC recalls CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack,…
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 properly lock the pump into…
FDA · DeviceThoratec LLCWorldwide - US Nationwide distribution including in the states of MN, PA, OK,…Official notice → - 2025-11-26
- US
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US;…
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
FDA · DeviceThoratec LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2025-08-20
- US
Thoratec LLC recalls Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product…
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.
FDA · DeviceThoratec LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2025-04-23
- US
Thoratec LLC recalls HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II…
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…
FDA · DeviceThoratec LLCWorldwide - US Nationwide distribution in the states of WA, NE, VA, PA, DC,…Official notice → - 2024-08-21
- US
Thoratec LLC recalls HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed…
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 printed circuit board…
FDA · DeviceThoratec LLCUS: MN, PA, FL, IL, NY, DE, AR, NJ, NC, GA, WI, AZ, TN, MO, TX, MA, OH, VA,…Official notice → - 2024-06-19
- US
Thoratec Corp. recalls Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and…
System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a…
FDA · DeviceThoratec Corp.Worldwide distribution. US nationwide including Puerto Rico, UNITED ARAB…Official notice → - 2024-05-08
- US
Thoratec Corp. recalls Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
FDA · DeviceThoratec Corp.Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL,…Official notice → - 2024-03-27
- US
Thoratec Corp. recalls HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption…
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
FDA · DeviceThoratec Corp.Worldwide distribution: U.S.(nationwide): AL,AR, AZ, CA, CO, CT, DC, DE, FL,…Official notice → - 2024-02-14
- US
Thoratec Corp. recalls 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch…
Due to software and controller systems that results in unexpected pump start or pump stop.
FDA · DeviceThoratec Corp.Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia,…Official notice → - 2023-10-11
- US
Thoratec Corp. recalls Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while…
FDA · DeviceThoratec Corp.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2021-12-08
- US
Thoratec Corp. recalls Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the…
FDA · DeviceThoratec Corp.Worldwide distribution - US Nationwide distribution in the states of FL, IL,…Official notice →