Thoratec HeartMate 3Recalls & reported problems across all models

We found 9 models of Thoratec HeartMate 3 by Thoratec Corporation in the FDA's device registry (GUDID). Together they are named in 21,215 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2018 and Sep 30, 2026 — classified as 5,110 deaths, 9,872 injuries, 6,230 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3,130 reports).

8 FDA recall records name at least one of these models by its device identifier, 5 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

Thoratec 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. 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-0505-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Jun 25, 2024Open, Classified

   Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop

   Z-2583-2024 · Root cause: Process design · names 3 of these models · Recall details · FDA record ↗

3. Mar 1, 2024Open, Classified

   Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

   Z-1692-2024 · Root cause: Device Design · Recall details · FDA record ↗

4. Feb 19, 2024Open, Classified

   Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

   Z-1301-2024 · Root cause: Material/Component Contamination · names 2 of these models · Recall details · FDA record ↗

5. Aug 7, 2023Open, Classified

   Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.

   Z-2658-2023 · Root cause: Process control · Recall details · FDA record ↗

6. Mar 30, 2019Terminated

   Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.

   Z-2349-2019 · Root cause: Process design · Recall details · FDA record ↗

7. Mar 30, 2019Terminated

   Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.

   Z-2348-2019 · Root cause: Process design · Recall details · FDA record ↗

8. Apr 5, 2018Terminated

   Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.

   Z-1774-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Thoratec HeartMate 3 problems

Thoratec HeartMate 3 models

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

• Thoratec® HeartMate 3™ 106524US

  Ventricular (Assisst) Bypass
  7 recalls5,096 deaths16,478 reports
• Thoratec® HeartMate 3™ 106531US

  Ventricular (Assisst) Bypass
  1 recall11 deaths4,646 reports
• Thoratec® HeartMate 3™ 105581US

  Ventricular (Assisst) Bypass
  2 recalls3 deaths38 reports
• Thoratec® HeartMate 3™ 106531LF2

  Ventricular (assist) bypass
  1 recall12 reports
• Thoratec® HeartMate 3™ 10005877

  Ventricular (assist) bypass
  22 reports
• Thoratec® HeartMate 3™ 10005872

  Ventricular (assist) bypass
  10 reports
• Thoratec® HeartMate 3™ 106522US

  Ventricular (assist) bypass
  7 reports
• Thoratec® HeartMate 3™ 106532US

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

  Ventricular (assist) bypass
  1 report

Recent Thoratec HeartMate 3 adverse event reports

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

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection

  MAUDE report 50954435 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952103 ↗
• DeathSep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was confirmed to have a profound hemorrhagic stroke through a computed tomography (CT) scan. The patient passed away. The outcome was not considered device or therapy related.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 50951854 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  There was a yellow-wrench icon on the System Controller. The patient performed System Controller exchange without discussing with their team.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951783 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951606 ↗
• MalfunctionSep 30, 2026Electrical Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951392 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951077 ↗
• MalfunctionSep 30, 2026Disconnection

  It was reported that the patient experienced numerous Power Cable Disconnect Alarms hours apart. It was said that the alarms occurred when the patient was walking, sitting, and lying down. The alarms were said to also have occurred before and after the patient fell while lying on a gurney. Upon initial interrogations the alarms did not appear to show on the System Controller nor Monitor. Log Files were submitted for review and captured unusual Power Cable Disconnect Alarms while the patient was on Battery Power. The alarms appeared to be the result of relative state of charge (RSOC) invalid flags. All connections were checked and different Batteries and two set of clips were tried but the alarms persisted. The alarms resolved when the System Controller was exchanged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951041 ↗
• DeathSep 30, 2026Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away due to circulatory arrest. The outcome was not considered device or therapy related. It was unknown if an autopsy was performed. The device was not explanted. According to the family, the running symbol was on and device alarmed Low Flow.

  Patient problems: Cardiac Arrest

  MAUDE report 50947779 ↗
• MalfunctionSep 30, 2026Infusion or Flow Problem

  It was reported that the patient had frequent Low Flow Alarms that did not appear to be correlated to any activity. The next was to obtain a computed tomography to assess for extrinsic Outflow Graft obstruction (EOGO). Log Files were sent for review. The Log File captured some intermittent Low Flow Event on 21Sep2026. The calculated flow appeared to have fluctuated below the alarm threshold of 2.5 LPM during the events. The Log File contained Low Flow estimates only when the calculated pulsatility index (PI) was dynamic and elevated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947296 ↗
• InjurySep 30, 2026Corroded; Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with bright blue/green drainage at the Driveline Exit Site (DLES), suspectected to be secondary to a confirmed pseudomonas culture which was obtained from the DLES. Internal Driveline corrosion was ruled out following irrigation and debridement of the exit site for infectious purposes. Antibiotics were administered. No Pump data appeared to be abnormal. Upon review of the submitted Log Files, no data indicated any electrical issues with the Driveline. There were no unusual events recorded in the Log File event history. The Mechanical Circulatory Support (MCS) equipment was noted to be operating as intended. The event was noted to be on track towards resolution, but not yet resolved.

  Patient problems: Bacterial Infection; Purulent Discharge

  MAUDE report 50947233 ↗
• DeathSep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through patient outcome that the patient passed away and the cause was unknown. The device was operating as intended when the police arrived at the patient's home. The Batteries were at 70% charge and rigor mortis had already set in with the patient. The outcome was not considered as Left Ventricle Assist Device (LVAD) or therapy related. The device was not explanted. The autopsy was not performed. The cause of death was not confirmed. The motel staff informed that the patient did have a fall a day prior and the patient was known to be well at 6pm the night before they passed away. The site suggested that there might be a neuro event but could not confirm it. The patient also had history of recurrent substance use. There was no evidence of self-harm or foul play, but also the event was unwitnessed and unexpected.

  Patient problems: Insufficient Information

  MAUDE report 50947192 ↗
• DeathSep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through the research article ¿Discharge prescription for neurohormonal blockade and clinical outcomes in HeartMate 3 LVAD recipients after device implantation¿ identifying that the HeartMate 3 (HM3) may be related to death/mortality and heart failure readmission. This is a single-center retrospective study where 273 patients who underwent HM3 Left Ventricular Assist Device (LVAD) implantation were evaluated. Of the 273 patients, 138 (50%) received a prescription for at least one neurohormonal blockade agent after index discharge. Patients who received neurohormonal blockade at index discharge had longer survival compared with those who did not, at a median follow-up of 3.8 years. After multivariate adjustment, neurohormonal blockade at discharge demonstrated a trend toward a lower risk of mortality (HR 0.69; 95% CI, 0.44¿1.09; p=0.11). A discharge prescription for neurohormonal blockade was not associated with heart failure readmission.

  Patient problems: Insufficient Information

  MAUDE report 50946984 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemodynamic instability

  MAUDE report 50946889 ↗
• MalfunctionSep 30, 2026Display or Visual Feedback Problem

  It was reported that the patient presented to the clinic with only one of the two green arrows in the Pump Running Symbol illuminated on the System Controller. Log Files were were submitted for evaluation. The Event Log File captured routine events. It was suggested to exchange the Controller.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946835 ↗

Other Thoratec Corporation products

• HeartMate7 models · 525 reports · 4 recalls
• THORATEC HEARTMATE, SYSTEM MONITOR2 models · 415 reports · 1 recall
• HeartMate 39 models · 298 reports · 3 recalls
• 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