HeartMateRecalls & reported problems across all models

We found 7 models of HeartMate by Thoratec Corporation in the FDA's device registry (GUDID). Together they are named in 525 adverse event reports in the FDA's MAUDE database, received between Aug 14, 2018 and Sep 30, 2026 — classified as 1 death, 7 injuries, 517 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (201 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HeartMate recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 13, 2026Open, Classified

   Due to 11 volt Backup Battery failures.

   Z-2520-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jun 23, 2025Open, Classified

   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.

   Z-2291-2025 · Root cause: Vendor change control · Recall details · FDA record ↗

3. Jun 23, 2025Open, Classified

   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.

   Z-2290-2025 · Root cause: Vendor change control · Recall details · FDA record ↗

4. Mar 13, 2025Open, Classified

   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.

   Z-1570-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported HeartMate problems

HeartMate models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HeartMate™ 107754

  Ventricular (assist) bypass
  2 recalls447 reports
• HEARTMATE® 1440

  Ventricular (Assisst) Bypass
  1 death67 reports
• HeartMate™ 107760

  Ventricular (assist) bypass
  1 recall6 reports
• HeartMate™ 106128

  Ventricular (assist) bypass
  1 recall0 reports
• HeartMate™ 1050

  Ventricular (assist) bypass
  3 reports
• HeartMate™ 1340

  Ventricular (assist) bypass
  1 report
• HeartMate™ 2865

  Ventricular (assist) bypass
  1 report

Recent HeartMate adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  It was reported that the Mobile Power Unit (MPU) patient cord fell into water, and the clinic advised the device should not be used. A warranty replacement was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948278 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902002 ↗
• MalfunctionSep 2, 2026Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572531 ↗
• MalfunctionAug 3, 2026Failure to Charge; Overheating of Device; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114961 ↗
• MalfunctionJul 27, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000808 ↗
• MalfunctionJun 11, 2026Failure to Power Up

  IT WAS REPORTED THAT THE MOBILE POWER UNIT (MPU) STOPPED WORKING AND WAS NOT TURNING ON AT ALL. THE MPU WOULD BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477671 ↗
• MalfunctionMay 10, 2026Use of Device Problem

  IT WAS REPORTED THAT THE MOBILE POWER UNIT (MPU) WAS CONSTANTLY, CONTENTLY, AND AUDIBLY ALARMING. THE BATTERIES WERE REPLACED, BUT THE ALARMS PERSISTED. THE MPU WAS REPLACED AND INTENDED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133439 ↗
• MalfunctionApr 28, 2026Mechanical Problem

  IT WAS REPORTED THAT REPLACEMENT WAS REQUESTED DUE TO DEFECTIVE THREAD ON THE CONNECTION OF THE MOBILE POWER UNIT (MPU) CABLE. WHEN CONNECTING THE DEVICE TO THE SYSTEM CONTROLLER, THERE WAS AN ISSUE WITH THE SCREW THREADS, CAUSING RESISTANCE AND STIFFNESS WHEN TURNING THE SCREW. IN ADDITION, IT WAS NOTED THAT IT WAS DIFFICULT TO VISUALLY IDENTIFY ANY DIFFERENCES. NO PATIENT CONSEQUENCE WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021507 ↗
• MalfunctionFeb 24, 2026Complete Loss of Power

  IT WAS REPORTED THAT FURTHER REVIEW OF THE LOG FILES CAPTURED NO EXTERNAL POWER ALARMS WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU). THE MPU HAD A V-LOCK CONNECTOR ON THE AC POWER CORD. THE CAUSE OF THE NO EXTERNAL POWER ALARMS WAS NOT IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434062 ↗
• MalfunctionFeb 10, 2026Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MOBILE POWER UNIT (MPU) ALARM. THE PATIENT REPORTED THAT THEY HAD IT PLUGGED INTO A SURGE PROTECTOR VERSUS A DIRECT WALL OUTLET. NO LOG FILES WERE AVAILABLE. THE PATIENT WAS TOLD TO WEAR BATTERIES AT NIGHT UNTIL MPU WAS EVALUATED AND REPAIRED. THE PATIENT WAS PROVIDED A LOANER MPU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306465 ↗
• MalfunctionFeb 5, 2026Failure to Power Up

  IT WAS REPORTED THAT THE PATIENT'S MOBILE POWER UNIT (MPU) WOULD NOT POWER UP ON THREE DIFFERENT OUTLETS AT HOME AND AFTER CHECKING POWER CABLES. THE PATIENT WAS ABLE TO GET IT TO TURN ON AND BROUGHT IT IN FOR REPLACEMENT AS THE PATIENT WAS AFRAID TO CONTINUE TO USE IT. THE MPU WAS TESTED AND WAS WORKING FINE, PASSED SELF-TESTS AND LOOKED FINE BUT THE PATIENT DID NOT WANT IT BACK. THE MPU HAD A V-LOCK CONNECTOR ON THE AC POWER CORD. A NEW MPU WAS GIVEN TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270781 ↗
• MalfunctionFeb 3, 2026Device Difficult to Setup or Prepare; Complete Loss of Power

  IT WAS REPORTED THAT DURING ROUTINE LOG FILE ANALYSIS, THE LOG FILES CAPTURED A LOSS OF POWER TO THE MOBILE POWER UNIT ON (B)(6) 2026. THE SYSTEM CONTINUED TO OPERATE AT THE SET SPEED AND WAS SUPPORTED BY THE SYSTEM CONTROLLER¿S BACKUP BATTERY UNTIL EXTERNAL POWER WAS RESTORED. THE MPU DID HAVE A V-LOCK CONNECTOR ON THE AC POWER CORD. THE AC POWER CORD CAME LOOSE AT THE WALL OUTLET. THE MPU WAS NOT REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251713 ↗
• MalfunctionFeb 2, 2026Complete Loss of Power

  IT WAS REPORTED THAT A REVIEW OF LOG FILES SHOWED POWER CABLE DISCONNECT AND NO EXTERNAL POWER WHILE CONNECTED TO MOBILE POWER UNIT (MPU) ON 15JAN2026, 17JAN2026 AND 21JAN2026. THIS WAS CAUSED BY POWER TO THE MPU BEING BRIEFLY INTERRUPTED. THE MPU DID NOT COME LOOSE AT THE WALL OUTLET OR FROM THE BACK OF THE UNIT. THE UNIT WAS EQUIPPED WITH A V-LOCK CONNECTOR ON THE AC POWER CORD. THERE WERE NOT ANY ENVIRONMENTAL CIRCUMSTANCES THAT WOULD HAVE AFFECTED AC POWER AT THE TIME OF THE EVENT. THE MPU REMAINED IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241622 ↗
• MalfunctionFeb 2, 2026Improper or Incorrect Procedure or Method; Complete Loss of Power

  IT WAS REPORTED THAT PATIENT ADMITTED ACCIDENTALLY DISCONNECTING MOBILE POWER UNIT (MPU) FROM OUTLET FORGETTING THEY WERE CONNECTED. THE PATIENT IMMEDIATELY SWITCHED TO BATTERY POWER BEFORE REALIZING THEY UNPLUGGED ACCIDENTLY. LOG FILES CAPTURED SEVERAL POWER LOSSES TO THE MOBILE POWER UNIT ON (B)(6) 2026. THE SYSTEM CONTINUED TO OPERATE AT THE SET SPEED AND WAS SUPPORTED BY BACKUP BATTERY UNTIL EXTERNAL POWER WAS RESTORED. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE MPU WAS EQUIPPED WITH A V-LOCK CONNECTOR ON THE AC POWER CORD. THE AC POWER CORD COME LOOSE AT THE WALL OUTLET OR FROM THE BACK OF THE UNIT. THE MPU REMAINED IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240727 ↗
• MalfunctionJan 20, 2026Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT WAS AT HOME UTILIZING THE MOBILE POWER UNIT (MPU) AND THE UNIT TURNED OFF. IT WAS BROUGHT TO THE HOSPITAL FOR EVALUATION AND COULD NOT BE CORRECTED. A NEW POWER CORD WAS TRIED ALONG WITH SEVERAL OUTLETS. THE MPU HAD A V-LOCK CONNECTOR ON THE AC POWER CORD. THE PATIENT WAS GIVEN A NEW MPU. THE MPU HAD A V-LOCK CONNECTOR AND THE AC POWER CORD DID NOT COME LOOSE. THE OLD MPU WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120922 ↗

Other Thoratec Corporation products

• Thoratec HeartMate 39 models · 21,215 reports · 8 recalls
• THORATEC HEARTMATE, SYSTEM MONITOR2 models · 415 reports · 1 recall
• HeartMate 39 models · 298 reports · 3 recalls
• HeartMate Touch3 models · 63 reports · 1 recall
• THORATEC HEARTMATE GOGEAR, SHOWER BAG2 models · 76 reports
• CentriMag3 models · 23 reports · 1 recall
• HeartMate II, System Controller2 models · 25 reports