HeartMate Touch™ HMT1100-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067033758), received between Sep 12, 2022 and Feb 13, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

31 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 3, 2024Class IOpen, Classified

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

   Z-0842-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Display or Visual Feedback Problem; Communication or Transmission Problem; Display or Visual Feedback Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE HEARTMATE TOUCH KIT LOST CONNECTION TO THE SYSTEM CONTROLLER DURING THE PRIMING OF THE PUMP, PRIOR TO IMPLANT. THE SESSION WAS ENDED AND RESTARTED. THE PRIMING CONTINUED AT 3000 RPM, BUT THE PRIMING WINDOW WAS NOT VIEWABLE. THE PUMP AUTOMATICALLY STOPPED POST COMPLETION OF THE ORIGINAL TIMER DESPITE THIS DATA NOT BEING VISIBLE. THERE WAS ALSO NO DISPLAY THAT THE PUMP STOP WAS COMPLETE AND THERE WAS NO RED LINE TO SHOW THIS EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697320 ↗
• MalfunctionDec 12, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING THE PRIMING OF THE PUMP, AND WHILE THE PUMP WAS CONNECTED TO THE HEARTMATE TOUCH MONITOR, THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR ASSUMED THE PRIMING PROCESS WAS DONE AND DISCONNECTED THE SYSTEM CONTROLLER POWER CABLES WHILE THE RED PUMP STOP LINE WAS FILLING. LATER, THE POWER CABLES WERE RECONNECTED WITH THE POWER MODULE AND AS SOON AS THE CONTROLLER WAS RECOGNIZED BY THE HEARTMATE TOUCH SYSTEM THE PUMP AUTO-STARTED AT 3000 RPM. THERE WAS NO IMPACT TO THE PATIENT AT THIS TIME, AS THE OUTFLOW GRAFT HAD ALREADY BEEN ATTACHED AND THE SURGEON HAD REQUESTED FOR THE PUMP TO BE STARTED WHEN THE RECONNECTION AND UNEXPECTED AUTOSTART HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314144 ↗
• MalfunctionSep 12, 2022Display or Visual Feedback Problem; Communication or Transmission Problem; Display or Visual Feedback Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION PROVIDED STATED THAT THE HEARTMATE TOUCH APP COULD NOT BE FORCE-CLOSED DUE TO IT BEING FROZEN. IT WAS REPORTED THAT THE ACCOUNT SWITCHED TO THE SYSTEM MONITOR AFTER THE ISSUE WAS OBSERVED. NO FURTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15404957 ↗

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-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-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-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 LV
• 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; 106531
• 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,
• 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-1692-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
• Z-1693-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
• Z-1300-2024 · Feb 19, 2024 · Open, Classified
  HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate

…and 16 more.