HeartMate Touch™ HMT2100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05415067032065), received between May 27, 2021 and Jan 2, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (5 reports).

32 other recalls cover devices cleared under the same FDA submission (P060040, P160054); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionOct 7, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE HEARTMATE TOUCH (HMT) WAS NOT CONNECTING TO ANY SYSTEM CONTROLLER. TROUBLESHOOTING WAS PERFORMED, THE APP WAS RESTARTED, THE IPAD WAS TURNED OFF AND ON, THE ADAPTER WAS UNPLUGGED, A NEW WIRELESS ADAPTER WAS TRIED, AND THE PATIENT CABLE WAS CHANGED OUT. THE HMT WOULD STILL NOT CONNECT TO THE SYSTEM CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20387790 ↗
• MalfunctionJul 30, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS ADDITIONALLY REPORTED THAT FOLLOWING TROUBLESHOOTING, THE HEARTMATE TOUCH ADAPTER WAS NOW FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19861853 ↗
• MalfunctionFeb 6, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE HEARTMATE TOUCH LOST CONNECTION TO THE SYSTEM CONTROLLER DURING THE PUMP PRIMING PHASE OF DEVICE SETUP. THE PRIMING WAS COMPLETED, AND THE ISSUE OCCURRED PRIOR TO DISCONNECTING THE DRIVELINE FROM THE MODULAR CABLE. THE SESSION ENDED AND REQUIRED RECONNECTION. THE PERFUSION TEAM ALSO NOTED FAILURE TO CONNECT THE ADAPTER TO THE HEARTMATE TOUCH WHEN THE DEVICE SET-UP WAS COMPLETED, AND THE EQUIPMENT WAS MOVED INTO THE THEATER READY FOR THE IMPLANT QUERY. THE BLUETOOTH DONGLE BUTTON WAS DEPRESSED, AND IT WAS NOTED THAT THE DONGLE FLASHED BLUE AND WENT TO THE HEARTMATE TOUCH. HM TOUCH COMMUNICATION SYSTEM MFR # 2916596-2024-00461.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652804 ↗
• MalfunctionDec 5, 2023Communication or Transmission Problem; Communication or Transmission Problem

  RELATED MANUFACTURER REPORT NUMBER: 2916596-2023-08312. IT WAS REPORTED THAT ON 26NOV2023, THE SYSTEM CONTROLLER WAS CONNECTED TO THE POWER MODULE VIA THE BLACK AND WHITE POWER CABLES. THE HEARTMATE TOUCH WAS ALSO CONNECTED TO THE POWER MODULE AND DISPLAYED THE DEVICE PARAMETERS. AT AROUND 18:30, THE DATA STOPPED DISPLAYING ON THE HEARTMATE TOUCH. THE CONNECTION BETWEEN THE HEARTMATE TOUCH AND SYSTEM CONTROLLER WAS RETRIED BUT DID NOT WORK. THE HEARTMATE TOUCH WAS UNABLE TO RECOGNIZE THAT THE SYSTEM CONTROLLER WAS CONNECTED. A NEW HEARTMATE TOUCH WAS TRIED WITH THE SAME CONTROLLER AND PATIENT CABLE BUT NOTHING CHANGED. THE PATIENT CABLE WAS THEN EXCHANGED BUT THE ISSUE PERSISTED. THE SYSTEM MONITOR WAS THEN CONNECTED, AND THE PARAMETERS WERE ABLE TO BE DISPLAYED. THE NEXT DAY, THE HEARTMATE TOUCH WIRELESS ADAPTER WAS EXCHANGED, AND THE ISSUE RESOLVED. THE ORIGINAL ADAPTER WAS TRIED AGAIN, TO SEE IF IT WOULD STILL WORK, AND IT FUNCTIONED AS INTENDED. BOTH ADAPTORS APPEARED TO WORK PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267440 ↗
• MalfunctionFeb 14, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SET PUMP SPEED OF 5200 AND A LOW-SPEED LIMIT OF 5000. THE PATIENT WAS CONNECTED TO THE POWER MODULE, BUT THE DOWNLOAD OF LOG FILES WAS NOT BEGUN BECAUSE THE IPAD WAS DEAD. THE HEALTHCARE PROFESSIONAL LEFT THE PATIENT PLUGGED INTO THE POWER MODULE AS THE IPAD WAS CHARGED. THE HEALTHCARE PROFESSIONAL COULD NOT REMEMBER IF THEY TOUCHED THE DONGLE AT ALL DURING THIS. WHEN THE HEALTHCARE PROFESSIONAL RETURNED TO THE PATIENT, THEY DISCONNECTED AND RECONNECTED THE DONGLE AS THE IPAD COULD NOT FIND THE DONGLE TO CONNECT, WHICH IS NOT UNUSUAL. THE HEALTHCARE PROFESSIONAL PERFORMED AN UNEVENTFUL DOWNLOAD AND EXPORT OF THE PATIENT'S LOG FILES. WHEN THE HEALTHCARE PROFESSIONAL WENT TO ANALYZE THE LOG FILES AND SUBMIT THE DATA, THEY NOTICED THAT THE HISTORICAL SPEED SETTING WAS 5200/5000 AND THE SPEED WAS CURRENTLY SET TO 5800/5400. THE HEALTHCARE PROFESSIONAL CONFIRMED THAT THE PATIENT HAD NOT HAD A RECENT RAMP STUDY AND THEY ELECTED TO CALL THE PATIENT BACK INTO THE OFFICE. THE PATIENT'S PUMP SPEED WAS CHANGED BACK TO 5200/5000 AND REDOWNLOADED THE LOG FILES. THE PATIENT WAS A LITTLE OUT OF BREATH AND TIRED BUT REPORTED NO OTHER SYMPTOMS AT THE TIME OF T

  Patient problems: Dyspnea

  MAUDE report 16376445 ↗
• MalfunctionFeb 13, 2023Communication or Transmission Problem; Data Problem; Communication or Transmission Problem; Data Problem

  IT WAS REPORTED THAT DURING A ROUTINE CLINIC VISIT, THERE WAS AN ISSUE WITH AN IPAD GLITCH. IT APPEARED THAT THE IPAD CHANGED THE PATIENT'S PUMP SPEED DURING A HEMATOCRIT CHANGE, BUT UPON FURTHER INVESTIGATION, IT APPEARED THAT THE IPAD SPORADICALLY CONNECTED TO A DIFFERENT DONGLE, WHICH WAS CONNECTED TO A DIFFERENT PATIENT, LEADING TO AN INAPPROPRIATE SPEED CHANGE. THE PATIENT WAS IN A ROOM WITH IPAD (B)(4) AND DONGLE (B)(4). THE PATIENT HAS A SET SPEED FOR 5800 AND A LOW-SPEED LIMIT OF 5400. THE WHITE POWER CABLE WAS CONNECTED TO THE POWER MODULE AND THE LOG FILE DOWNLOAD BEGAN. THE HEALTHCARE PROFESSIONAL LEFT THE ROOM TO TEND TO ANOTHER PATIENT. WHEN THEY RETURNED, THE SCREEN BEGAN TO GLITCH. IT FLICKERED MULTIPLE TIMES WHEN THE HEALTHCARE PROFESSIONAL TRIED TO SET THE HEMATOCRIT AND THE SET SPEED APPEARED TO BE CHANGING. THE FLICKERING WAS VERY QUICK, SO THEY WERE UNABLE TO READ WHAT THE IPAD REPORTED. THE DATA DOWNLOAD WAS OPENED TO EXPORT IT ONTO A THUMB DRIVE. IT WAS NOTED THAT THERE WAS A DISCREPANCY BETWEEN THE SPEED REPORTED IN THE DATA DOWNLOAD AND THE SET SPEED IN THE HEARTMATE TOUCH APP, WHICH STATED 5200/5000 INSTEAD OF 5800/5400. THE HEALTHCARE PROFESSIONAL CONFIRME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16369467 ↗
• MalfunctionSep 28, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PAIRING BUTTON ON THE HEARTMATE TOUCH BLUETOOTH ADAPTOR WAS NOT WORKING PROPERLY. THE ITEM WAS NEW AND BELIEVED TO BE UNDER WARRANTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540381 ↗
• InjuryMay 27, 2021Pumping Stopped; Pumping Stopped

  RELATED MANUFACTURER REPORT NUMBERS: 2916596-2021-02659 AND 2916596-2021-02660.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 11895066 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060040, P160054. One submission often covers many models, so check the product and lot details in each record.

• Z-2518-2026 · May 13, 2026 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left
• Z-2519-2026 · May 13, 2026 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts
• Z-2520-2026 · May 13, 2026 · Open, Classified
  Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Stan
• Z-0507-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate II LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II LVAS
• Z-0508-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate II Controller (standalone) Model/Catalog Number: 106017, HeartMate II Pocket Controller, US; 106762, HeartMate II Pocket Controller, U
• Z-0506-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF
• Z-0505-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS;
• Z-2290-2025 · Jun 23, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assis
• Z-2291-2025 · Jun 23, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS)
• Z-1570-2025 · Mar 13, 2025 · Open, Classified
  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.
• Z-2583-2024 · Jun 25, 2024 · Open, Classified
  HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Ki
• Z-1921-2024 · May 8, 2024 · Open, Classified
  Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
• Z-1693-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
• Z-1692-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
• Z-1301-2024 · Feb 19, 2024 · Open, Classified
  HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graf

…and 17 more.