Thoratec recalls
Thoratec appears in 31 official U.S. recall notices indexed by RecallRadar, most recently on 2026-06-24.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 31 |
|---|---|
| Published | 2014-04-02 to 2026-06-24 |
| By agency | FDA Device (31) |
| By classification | Class I (16), Class II (15) |
| By status | ongoing (20), terminated (11) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, US, UT, VA, WA, WI, WV |
Recalls
- Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description…
FDA Device · Class II · 2026-06-24 · Thoratec
Reason: Due to 11 volt Backup Battery failures. - Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Pr…
FDA Device · Class II · 2026-06-24 · Thoratec
Reason: Due to 11 volt Backup Battery failures. - Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Descriptio…
FDA Device · Class II · 2026-06-24 · Thoratec
Reason: Due to 11 volt Backup Battery failures. - CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016
FDA Device · Class II · 2026-01-21 · Thoratec
Reason: 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 motor… - Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US
FDA Device · Class II · 2025-11-26 · Thoratec
Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. - Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Contro…
FDA Device · Class II · 2025-11-26 · Thoratec
Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. - Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US
FDA Device · Class II · 2025-11-26 · Thoratec
Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. - Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US
FDA Device · Class II · 2025-11-26 · Thoratec
Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. - Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description…
FDA Device · Class I · 2025-08-20 · Thoratec
Reason: 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. - Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate…
FDA Device · Class I · 2025-08-20 · Thoratec
Reason: 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. - HeartMate Mobile Power Unit: REF: 107754, NA
FDA Device · Class I · 2025-04-23 · Thoratec
Reason: 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 Wre… - HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed…
FDA Device · Class II · 2024-08-21 · Thoratec
Reason: 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 assemblies… - Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286…
FDA Device · Class I · 2024-06-19 · Thoratec
Reason: 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 command,… - Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Device · Class I · 2024-05-08 · Thoratec
Reason: Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. - Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Device · Class I · 2024-05-08 · Thoratec
Reason: Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. - HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS I…
FDA Device · Class I · 2024-03-27 · Thoratec
Reason: Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System. - HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (…
FDA Device · Class I · 2024-03-27 · Thoratec
Reason: Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System. - 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Commu…
FDA Device · Class I · 2024-02-14 · Thoratec
Reason: Due to software and controller systems that results in unexpected pump start or pump stop. - Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT
FDA Device · Class II · 2023-10-11 · Thoratec
Reason: 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… - Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
FDA Device · Class II · 2021-12-08 · Thoratec
Reason: 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 sys… - HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the Hear…
FDA Device · Class II · 2020-01-08 · Thoratec
Reason: Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow… - Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
FDA Device · Class II · 2019-08-28 · Thoratec
Reason: Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant… - Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (…
FDA Device · Class II · 2019-08-28 · Thoratec
Reason: Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant… - Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist…
FDA Device · Class II · 2019-05-01 · Thoratec
Reason: Small black plastic particle was observed in the left ventricle during implant procedure. - HeartMate¿ II LVAS with Pocket Controller
FDA Device · Class I · 2017-05-31 · Thoratec
Reason: St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/12… - HeartMate¿ II LVAS with Pocket Controller
FDA Device · Class I · 2017-05-31 · Thoratec
Reason: St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/12… - HeartMate¿ II LVAS with Pocket Controller
FDA Device · Class I · 2017-05-31 · Thoratec
Reason: St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/12… - HeartMate II LVAD Pump and Pock Controller Kit
FDA Device · Class I · 2014-04-02 · Thoratec
Reason: Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model. - HeartMate II Implant Kit with Pocket Controller
FDA Device · Class I · 2014-04-02 · Thoratec
Reason: Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model. - Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout…
FDA Device · Class I · 2014-04-02 · Thoratec
Reason: Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model. - HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart…
FDA Device · Class I · 2014-04-02 · Thoratec
Reason: Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.