HeartMate 3™ 106531USRecalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 05415067039446), received between Aug 27, 2025 and Sep 30, 2026 — classified as 1 injury, 71 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (29 reports).

2 FDA recall records name this device's identifier, 2 still open.

16 other recalls cover devices cleared under the same FDA submission (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 16, 2026.

Recalls naming this device

1. May 13, 2026Open, Classified

   Due to 11 volt Backup Battery failures.

   Z-2519-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Oct 9, 2025Open, Classified

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

   Z-0506-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951890 ↗
• MalfunctionSep 30, 2026Electrical Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951494 ↗
• MalfunctionSep 30, 2026Communication or Transmission Problem

  It was reported that the patient experienced a Driveline Communication Fault on (b)(6)2026. The patient panicked and switched to their backup System Controller. The patient stated that after a few minutes, the backup Controller had the same error, so they switched back to their primary Controller. Review of Log Files from the primary Controller found single Communication Faults (COMM A) starting at 15:53 on (b)(6)2026 that continued until the Controller was exchanged at 15:55. Review of the backup Controller Log File showed the Driveline was connected at 15:55 on (b)(6)2026 and COMM A Faults reoccurred at 17:39, with the patient switching back to the original Controller at 17:46. No further COMM faults were noted in the Log Files after the patient switched back to the original primary Controller. The customer stated that there were no visible cracks, slits, or damage to Pump or Modular Cables. However, some debris was noted around the yellow line at the Modular Cable-Pump Cable connector. That debris was cleaned. The patient was then provided a new System Controller and Modular Cable. There were no further alarms reported following the exchange to the new Controller and new Modular

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947171 ↗
• MalfunctionSep 30, 2026Communication or Transmission Problem

  It was reported that the patient experienced a Driveline Communication Fault on (b)(6)2026. The patient panicked and switched to their backup System Controller. The patient stated that after a few minutes, the backup Controller had the same error, so they switched back to their primary Controller. Review of Log Files from the primary Controller found single Communication Faults (COMM A) starting at 15:53 on (b)(6)2026 that continued until the Controller was exchanged at 15:55. Review of the backup Controller Log File showed the Driveline was connected at 15:55 on (b)(6)2026 and COMM A Faults reoccurred at 17:39, with the patient switching back to the original Controller at 17:46. No further COMM faults were noted in the Log Files after the patient switched back to the original primary Controller. The customer stated that there were no visible cracks, slits, or damage to Pump or Modular Cables. However, some debris was noted around the yellow line at the Modular Cable-Pump Cable connector. That debris was cleaned. The patient was then provided a new System Controller and Modular Cable. There were no further alarms reported following the exchange to the new Controller and new Modular

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947132 ↗
• MalfunctionSep 29, 2026Electrical Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937437 ↗
• MalfunctionSep 29, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936827 ↗
• MalfunctionSep 28, 2026Disconnection; Electrical /Electronic Property Problem; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926397 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923269 ↗
• MalfunctionSep 25, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902409 ↗
• MalfunctionSep 25, 2026Mechanical Problem

  It was reported that when removing the retaining screws to install the Emergency Backup Battery (EBB) on the pocket System Controller, one screw head broke off, and the cover could not be removed. The customer requested replacement for out of box failure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899659 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  It was reported that the patient had Driveline Power Fault. The Log Files were submitted for review and the Modular Cable was exchanged. The alarm resolved after System Controller was exchanged. There was no evident erosion at the Modular Cable site. The Event Log File review showed dates from (b)(6) 2026. The Event Log File captured Driveline Power Faults (Power B) starting from the beginning of the data and continued for the remainder of the Log File. The picture provided showed the inline connector to be clean with no notable debris or corrosion.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896729 ↗
• MalfunctionSep 24, 2026Failure to Charge; Electrical Power Problem

  It was reported that the patient performed a System Controller exchange at home after an Emergency Backup Battery Fault Alarm. Upon review of the submitted Log Files, Low Power Advisory events were observed that appeared to be associated with a poor connection between the Battery Contacts and the Battery Clip Contacts. The Log File recorded a Backup Battery fault event that appeared to have occurred after the System Controller attempted a Load Test. A Driveline Disconnect event was also recorded. The alarm did not return after the Battery was changed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888892 ↗
• MalfunctionSep 24, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888815 ↗
• MalfunctionSep 24, 2026Pumping Stopped; Improper or Incorrect Procedure or Method

  It was reported that the patient fell asleep while supported on Battery Power. On 01Sep2026 at approximately 08:10, the Left Ventricular Assist Device (LVAD) stopped due to loss of Power to the System Controller. Upon awakening, the patient contacted the clinical team, and at approximately 11:22, was guided through a Battery exchange procedure. During the Battery change, a Power Cable Disconnect Alarm was heard, and the patient confirmed that the Battery light was green. Following restoration of Power, the Pump restarted, Pump parameters returned to baseline, and the patient reported feeling well. Review of the HeartMate Log File confirmed Pump Stop Alarms at approximately 08:10 on 01Sep2026 resulting from loss of Power to the System Controller. The Log File showed that Low Power Advisory Alarms began at 03:11 and progressed to Low Power Hazard Alarms at 05:48. No External Power Alarms began at 06:05 after the external Batteries became depleted. The Controller subsequently operated on the Emergency Backup Battery until the Pump shut off. Review of the Log File further indicated that the patient had not connected to the Power Module (PM) or Mobile Power Unit (MPU) during the reviewe

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888531 ↗
• MalfunctionSep 24, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885731 ↗
• MalfunctionSep 24, 2026Failure to Charge

  It was reported that the Log files were submitted for evaluation for Backup Battery Fault Alarms. The Backup battery was changed in the primary System Controller and Backup Battery Fault alarms persisted despite syncing clock, they waited 10 minutes after changing, and there was 28 months left on the new Battery. It appeared the Event Log File recorded a Backup Battery Fault event on 02Sep2026 at 2:27:37. This event appeared to have occurred after the System Controller attempted a Load Test. The primary System Controller was exchanged and the alarms resolved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883799 ↗
• MalfunctionAug 31, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50523464 ↗
• MalfunctionAug 26, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458634 ↗
• MalfunctionAug 21, 2026Disconnection; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379032 ↗
• MalfunctionAug 18, 2026Electrical /Electronic Property Problem; Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308025 ↗
• MalfunctionAug 10, 2026Data Problem

  It was reported that the patient experienced persistent Low Flow Hazard alarms, prompting a request for a Low Flow alarm upgrade. The System Controller was subsequently exchanged for a Low Flow Controller. Upon interrogation of the log files, only limited historical data was available. To investigate the issue, the System Monitor was replaced; however, the historical view continued to display limited data. Limited data was showing on both Controllers.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50198473 ↗
• MalfunctionAug 4, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133534 ↗
• MalfunctionFeb 17, 2026Display or Visual Feedback Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SYSTEM CONTROLLER EXCHANGE WAS PERFORMED BY THE NURSE AFTER STATING THERE WAS A FAULT ALARM DISPLAYED ON THE SYSTEM CONTROLLER SCREEN BEFORE THE SYSTEM CONTROLLER WENT BLANK. LOG FILE REVIEW REVEALED NO UNUSUAL EVENT PRIOR TO THE SYSTEM CONTROLLER EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368573 ↗
• MalfunctionFeb 4, 2026Mechanical Problem

  IT WAS REPORTED THE BACKUP SYSTEM CONTROLLER ISSUED DURING IMPLANT HAD A BROKEN SCREW. THE SYSTEM CONTROLLER WAS NOT USED AND A DIFFERENT SYSTEM CONTROLLER WAS ISSUED AS A BACKUP. ADDITIONALLY IT WAS REPORTED THAT THERE WAS A BROKEN SCREW HEAD ON THE PATIENT'S PRIMARY SYSTEM CONTROLLER WHEN ATTEMPTING TO CLOSE COVER AFTER INSERTING THE EMERGENCY BACKUP BATTERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260191 ↗
• MalfunctionFeb 4, 2026Mechanical Problem

  IT WAS REPORTED THE BACKUP SYSTEM CONTROLLER ISSUED DURING IMPLANT HAD A BROKEN SCREW. THE SYSTEM CONTROLLER WAS NOT USED AND A DIFFERENT SYSTEM CONTROLLER WAS ISSUED AS A BACKUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260128 ↗

Recalls under the same FDA submission

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

• 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-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-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-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-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
• Z-0842-2024 · Jan 3, 2024 · Open, Classified
  1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate T
• Z-0746-2020 · Dec 2, 2019 · Terminated
  HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, R
• Z-2349-2019 · Mar 30, 2019 · Terminated
  Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
• Z-2348-2019 · Mar 30, 2019 · Terminated
  Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System

…and 1 more.