Thoratec Recalls

30 recalls on record in the United States

medical: 30
medical Class I
2017-05-31

Thoratec Corporation recalls HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII P

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-1227/1230-2014.

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medical Class I
2017-05-31

Thoratec Corporation recalls HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII P

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-1227/1230-2014.

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medical Class I
2017-05-31

Thoratec Corporation recalls HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII L

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-1227/1230-2014.

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medical Class II
2026-01-21

Thoratec LLC recalls CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201

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 my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.

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medical Class II
2025-11-26

Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3 Controller

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

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medical Class II
2025-11-26

Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate II¿ Controlle

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

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medical Class II
2025-11-26

Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Impl

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

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medical Class II
2025-11-26

Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3 Left Ventri

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

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medical Class I
2025-08-20

Thoratec LLC recalls Brand Name: HeartMate Product Name: Mobile Power Unit, AC P

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.

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medical Class I
2025-08-20

Thoratec LLC recalls Brand Name: HeartMate Product Name: Mobile Power Unit Mode

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.

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medical Class I
2025-04-23

Thoratec LLC recalls HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 10

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 Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.

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medical Class II
2024-08-21

Thoratec LLC recalls HeartMate 3 System Controllers provided within the following

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, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop

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medical Class II
2024-07-03

Thoratec Switzerland GMBH recalls 2nd Generation CentriMag Primary Console, REF: 201-90401, 20

Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.

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medical Class I
2024-06-19

Thoratec Corp. recalls Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A,

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, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected

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medical Class I
2024-05-08

Thoratec Corp. recalls Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Steril

Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

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medical Class I
2024-05-08

Thoratec Corp. recalls Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Steri

Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

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medical Class I
2024-03-27

Thoratec Corp. recalls HeartMate 3 Left Ventricular Assist System (LVAS): 1. Heart

Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

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medical Class I
2024-03-27

Thoratec Corp. recalls HeartMate II Left Ventricular Assist System (LVAS): 1. Hear

Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

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medical Class I
2024-02-14

Thoratec Corp. recalls 1. HeartMate Touch Communication System, REF HMT1100 2. Hea

Due to software and controller systems that results in unexpected pump start or pump stop.

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medical Class II
2023-10-11

Thoratec Corp. recalls Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Hear

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 the backup coring knife is acquired.

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medical Class II
2021-12-08

Thoratec Corp. recalls Abbott HeartMate Touch Communication System, REF: HMT1100 (U

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 system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.

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medical Class II
2020-01-08

Thoratec Corp. recalls HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 0081

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 from the left ventricular assist system.

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medical Class I
2019-11-06

Thoratec Switzerland GMBH recalls CentriMag Acute Circulatory Support System Motor, U.S. Model

Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).

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medical Class II
2019-08-28

Thoratec Corp. recalls Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief,

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 procedure.

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medical Class II
2019-08-28

Thoratec Corp. recalls Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/1

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 procedure.

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medical Class II
2019-05-01

Thoratec Corp. recalls Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF

Small black plastic particle was observed in the left ventricle during implant procedure.

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medical Class II
2018-10-24

Thoratec Switzerland GMBH recalls Thoratec CentriMag Motor, Model: 102956, a component of the

Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection.

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medical Class II
2026-06-24

Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3" System Con

Due to 11 volt Backup Battery failures.

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medical Class II
2026-06-24

Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3 Left Ventri

Due to 11 volt Backup Battery failures.

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medical Class II
2026-06-24

Thoratec LLC recalls Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Ba

Due to 11 volt Backup Battery failures.

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