HeartMate 3Recalls & reported problems across all models

We found 9 models of HeartMate 3 by Thoratec Corporation in the FDA's device registry (GUDID). Together they are named in 298 adverse event reports in the FDA's MAUDE database, received between Aug 16, 2023 and Sep 30, 2026 — classified as 123 deaths, 64 injuries, 111 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (57 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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 3 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-2519-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 13, 2026Open, Classified

   Due to 11 volt Backup Battery failures.

   Z-2518-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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 · names 2 of these models · Recall details · FDA record ↗

Most reported HeartMate 3 problems

HeartMate 3 models

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

• HeartMate 3™ 106524US

  Ventricular (assist) bypass
  1 recall123 deaths207 reports
• HeartMate 3™ 106531US

  Ventricular (assist) bypass
  2 recalls72 reports
• HeartMate 3™ 106531LF2

  Ventricular (assist) bypass
  1 recall0 reports
• HeartMate 3™ 106525US

  Ventricular (assist) bypass
  13 reports
• HeartMate 3™ 10002222US

  Ventricular (assist) bypass
  2 reports
• HeartMate 3™ 10010372GBL

  Ventricular (assist) bypass
  1 report
• HeartMate 3™ 10005872

  Ventricular (assist) bypass
  1 report
• HeartMate 3™ 106522US

  Ventricular (assist) bypass
  1 report
• HeartMate 3™ 106528US

  Ventricular (assist) bypass
  1 report

Recent HeartMate 3 adverse event reports

The 15 most recent reports across all models, 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, 2026Contamination /Decontamination 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 50947208 ↗
• 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 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Hemodynamic instability; Thrombosis/Thrombus

  MAUDE report 50936065 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Stroke/CVA; Thromboembolism

  MAUDE report 50935955 ↗
• MalfunctionSep 28, 2026Disconnection; Electrical /Electronic Property Problem; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926397 ↗
• InjurySep 28, 2026Mechanical Problem; Overheating of Device; Pumping Stopped; Infusion or Flow Problem

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50926389 ↗
• MalfunctionSep 28, 2026Device Difficult to Setup or Prepare

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923776 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923275 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923269 ↗
• DeathSep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away. The cause of death was not provided. The patient detached from power. An autopsy would not be performed. The Pump was not explanted.

  Patient problems: Insufficient Information

  MAUDE report 50916454 ↗

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 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