HeartMate TouchRecalls & reported problems across all models

We found 3 models of HeartMate Touch by Thoratec Corporation in the FDA's device registry (GUDID). Together they are named in 63 adverse event reports in the FDA's MAUDE database, received between May 27, 2021 and Sep 28, 2026 — classified as 1 injury, 62 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (28 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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 Touch 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. Jan 3, 2024Open, Classified

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

   Z-0842-2024 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

Most reported HeartMate Touch problems

HeartMate Touch models

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

• HeartMate Touch™ HMT1100

  Ventricular (assist) bypass
  1 recall50 reports
• HeartMate Touch™ HMT1100-R

  Ventricular (assist) bypass
  1 recall3 reports
• HeartMate Touch™ HMT2100

  Ventricular (assist) bypass
  10 reports

Recent HeartMate Touch adverse event reports

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

• MalfunctionSep 28, 2026Communication or Transmission Problem

  It was reported that during preparation of a HeartMate 3 system in the operating room, communication with the system was lost after the Pump had been primed and while the team was attempting to turn it off. The red Line never completed across the screen and the Pump started back up. Troubleshooting was performed, including disconnecting the Bluetooth adapter, rebooting the adapter, and attempting to reconnect the system. Communication was temporarily restored; however, the connection was lost again during a subsequent priming attempt. The entire system cart, including the Power Module, HM Touch iPad, Patient Cable, and Bluetooth adapter, was sent to biomedical engineering team for evaluation. The equipment reportedly passed testing and was returned for clinical use. However, after being connected to a patient in the intensive care unit, communication was again lost after approximately five minutes of operation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915584 ↗
• MalfunctionSep 24, 2026Communication or Transmission Problem

  It was reporting that after Pump preparation was completed, the HeartMate Touch (HMT) abruptly lost connection to the System Controller. All connections were checked and secured. The Bluetooth connection was stable. Extended silence was noted to be disengaged. There were attempts to reconnect to the Controller, but the Screen would not verify the connection. Images were submitted of the issue. A new HMT was obtained and there were no further issues at that time. During the case, multiple attempts were made to start the Pump, but the command would not go through and the Pump would not start. The Power was stable at 0.8W. Usual alarms were present on the Controller, including Pump Off Alarms, Low Flow Alarms, and Backup Battery Not Installed Alarms. A new Ventricular Assist Device (VAD) cart was obtained with a HMT, a Bluetooth adapter, and a new System Controller. A Controller exchange was performed. No further connectivity issues or alarms occurred after the exchange. The customer requested a replacement Controller.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887183 ↗
• MalfunctionFeb 2, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE HEARTMATE TOUCH (HMT) WAS NOT RECOGNIZING TOUCH MULTIPLE TIMES DURING PUMP PREP IN THE OPERATING ROOM (OR). THE SCREEN WAS NOT SENSITIVE TO TOUCH ATTEMPTS TO PRIME THE PUMP. THE APP WAS CLOSED OUT AND OPENED AGAIN. THE APP WORKED INTERMITTENTLY WITH TOUCHES ON THE TABLET, AND THE HMT WAS TAKEN TO BIOMED FOR TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231128 ↗
• MalfunctionJan 2, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH CONNECTING THE HEARTMATE TOUCH WIRELESS BLUETOOTH ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944794 ↗
• MalfunctionDec 29, 2025Premature Discharge of Battery; Failure to Interrogate; Manufacturing, Packaging or Shipping Problem; Failure to Interrogate; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE HOSPITAL ORDERED A HEARTMATE (HM) TOUCH COMMUNICATION SYSTEM AND THE IPAD WAS NOT ABLE TO LINK TO THE BLUETOOTH ADAPTER AND WELL AS KEEP CHARGE. TROUBLESHOOTING WAS PERFORMED AND IT STILL DID NOT WORK WHEN TRIED TO CONNECT TO A DIFFERENT BLUETOOTH ADAPTER. THE BLUETOOTH ADAPTER IN THE KIT WAS ABLE TO CONNECT TO A DIFFERENT HM TOUCH. THE CENTER WOULD BE RETURNING THE HM TOUCH COMMUNICATION SYSTEM FOR OUT OF BOX FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908212 ↗
• MalfunctionDec 4, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE SITE EXPERIENCED A LOST CONNECTION BETWEEN THE HEARTMATE TOUCH AND THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) DURING PUMP PREPARATION. THE CONNECTION WAS RE-ESTABLISHED TO END THE PUMP PREPARATION, AND THE HEARTMATE 3 WAS IMPLANTED WITHOUT ANY OTHER ISSUES. THE PATIENT LATER EXPERIENCED LOW FLOW AND PUMP OFF ALARMS. THE PUMP WAS CONFIRMED TO BE OFF. THE HEARTMATE TOUCH READ BLANK REVOLUTIONS PER MINUTE (RPM), 0.0 LITERS PER MINUTE, AND POWER AT 1.4 WATTS. THE SITE RECEIVED AN ERROR MESSAGE WHEN THEY ATTEMPTED TO CHANGE THE RPM. THE SITE WAS NOT ABLE TO START THE STOPPED PUMP USING THE HEARTMATE TOUCH, CHANGING SYSTEM CONTROLLERS, OR POWER CYCLING BY DISCONNECTING THE DRIVELINE AT THE SYSTEM CONTROLLER. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR AN URGENT PUMP EXCHANGE. LOG FILES WERE SENT FOR REVIEW. THE LOG FILES DID NOT DISPLAY ANY USABLE DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720574 ↗
• MalfunctionJul 16, 2025Overheating of Device; Failure to Power Up; Overheating of Device; Failure to Power Up

  IT WAS REPORTED THAT THE HEARTMATE IPAD DID NOT TURN ON DESPITE BEING FULLY CHARGED. THE IPAD WAS ABLE TO BE TURNED ON ONE HOUR LATER BUT WAS WARM TO THE TOUCH. LATER IN THE DAY, MULTIPLE ATTEMPTS WERE MADE TO TURN ON THE HEARTMATE TOUCH IPAD, BUT IT DID NOT TURN ON AND FUNCTION. MULTIPLE ATTEMPTS WERE MADE TO RESTART THE DEVICE WITH NO SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523003 ↗
• MalfunctionJun 26, 2025Failure to Power Up; No Apparent Adverse Event; Failure to Power Up; No Apparent Adverse Event

  FURTHER REVIEW OF THE SUBMITTED LOG FILES REVEALED THAT THE PUMP STOP EVENT APPEARED TO BE THE RESULT OF THE SYSTEM CONTROLLER SENDING A COMMAND TO DISABLE PUMP AUTO-START, PER DESIGN, DUE TO THE PUMP RESETTING WHILE THE SET SPEED WAS BELOW 4000 REVOLUTIONS PER MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340852 ↗
• MalfunctionJun 20, 2025Failure to Interrogate; No Apparent Adverse Event; Failure to Interrogate; No Apparent Adverse Event

  IT WAS REPORTED THAT THE LOG FILES WERE PROVIDED FOR THE SYSTEM CONTROLLER EXCHANGE AND IT WAS DUE TO A BLANK SCREEN ON THE HEARTMATE TOUCH DEVICE. AFTER THE SYSTEM CONTROLLER EXCHANGE IT LOOKED AS THOUGH THE DEVICE WAS FUNCTIONING AS INTENDED. THERE WERE SOME CONCERNS ABOUT BLANKING FLOWS BUT THE FLOW LOOKED SOLID IN THE LIMITED DATA PROVIDED. IT WAS REQUESTED THAT THE LOG FILES FROM THE EXCHANGED SYSTEM CONTROLLER BE PROVIDED AS IT MAY HAVE MORE PERTINENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301422 ↗
• MalfunctionJun 16, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE LEFT VENTRICULAR ASSIST DEVICE CART, SPECIFICALLY WITH THE IPAD SCREEN, WHICH WOULD NOT TURN ON. UPON INSPECTION, THE TECHNICIAN WAS NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE ISSUE. ADDITIONAL TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE DID NOT RESOLVE. THE SCREEN WAS REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212523 ↗
• MalfunctionJun 11, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE SYSTEM CONTROLLER LOST CONNECTION WITH THE HEARTMATE TOUCH TABLET. THE TABLET SHOWED "END SESSION" AS IF THE SYSTEM CONTROLLER WAS DISCONNECTED. "END SESSION" WAS PUSHED AND WAITED FOR THE CONNECTION TO RESUME. THE SYSTEM CONTROLLER WAS NOT CONNECTING AND BLUETOOTH CONNECTION WAS LOST. THE BLUETOOTH ADAPTER WAS UNPLUGGED AND PLUGGED BACK IN. THE HEARTMATE TOUCH APP WAS CLOSED OUT, AND THEN BLUETOOTH CONNECTION WAS ESTABLISHED AGAIN AND THEY WERE ABLE TO MOVE ON WITH THE PROCEDURE. WHEN THE PUMP WAS TURNED ON THE "PROCESSING..." SCREEN STAYED ON LONGER THAN USUAL. SYSTEM CONTROLLER ALARMED DUE TO LOSS OF CONNECTION AND LOSS OF EXTENDED ALARM SILENCE. RED HEART, DRIVELINE DISCONNECT SINCE WE WERE NOT FULLY ASSEMBLED AS NORMAL PART OF THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185674 ↗
• MalfunctionApr 22, 2025Failure to Charge; Failure to Interrogate; Failure to Power Up; Failure to Charge; Failure to Interrogate; Failure to Power Up

  IT WAS REPORTED THAT THE HEARTMATE TOUCH COMMUNICATION SYSTEM WOULD NOT TURN ON OR CHARGE, AND MULTIPLE CHARGERS WERE TRIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885894 ↗
• MalfunctionApr 2, 2025Failure to Interrogate; Device Difficult to Setup or Prepare; Failure to Interrogate; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE HEARTMATE TOUCH (HMT) WOULD NOT CONNECT WHEN PRESSING THE GRAY BUTTON ON THE SERIAL ADAPTER. IT WAS ATTEMPTED WITH A SECOND SERIAL ADAPTER WITH THE SAME ISSUE OCCURRING. THE CLINIC TRIED POWER CYCLING THE HMT AND THERE WAS STILL NO CONNECTION. IT WAS NOTED THAT IT WAS ABLE TO BE CONNECTED IN CLINIC AND THE CUSTOMER WOULD CONTINUE TO MONITOR. NO PRODUCT WOULD RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755383 ↗
• MalfunctionApr 1, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT HEARTMATE TOUCH SCREEN WAS BLANK. IT WAS CHARGED ALL EVENING. THERE WAS SOMETHING ON AS THE SCREEN LIT UP AND THE NOISE WHEN THE SCREEN WAS LOCKED STILL OCCURRED, BUT THE SCREEN WAS BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21744131 ↗
• MalfunctionFeb 12, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT WAS ON NORMAL WARD AND IT WAS NOT POSSIBLE TO CONNECT BLUETOOTH FROM THE IPAD. THE BUTTON FROM WIRELESS ADAPTER WAS NOT ON NORMAL POSITION. IT WAS NOTED THAT THE ADAPTER DID NOT CHANGE COLOR. THE ADAPTER WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21369073 ↗

Other Thoratec Corporation products

• Thoratec HeartMate 39 models · 21,215 reports · 8 recalls
• HeartMate7 models · 525 reports · 4 recalls
• THORATEC HEARTMATE, SYSTEM MONITOR2 models · 415 reports · 1 recall
• HeartMate 39 models · 298 reports · 3 recalls
• THORATEC HEARTMATE GOGEAR, SHOWER BAG2 models · 76 reports
• CentriMag3 models · 23 reports · 1 recall
• HeartMate II, System Controller2 models · 25 reports