Thoratec® HeartMate 3™ 106524USRecalls & reported problems

Summary

The FDA's MAUDE database contains 16,478 adverse event reports that list this exact device (DI 00813024013297), received between Jun 12, 2018 and Sep 30, 2026 — classified as 5,096 deaths, 9,665 injuries, 1,716 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3,084 reports).

7 FDA recall records name this device's 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, 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. Oct 9, 2025Class IIOpen, 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, 2024Class IIOpen, 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 · Recall details · FDA record ↗

3. Mar 1, 2024Class IOpen, 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, 2024Class IOpen, 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 · Recall details · FDA record ↗

5. Aug 7, 2023Class IIOpen, 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, 2019Class IITerminated

   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 ↗

7. Apr 5, 2018Class ITerminated

   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 problems

Recent adverse event reports

The 25 most recent of 16,478 reports, 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951077 ↗
• 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 ↗
• DeathSep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through the patient outcome that the patient passed away. The cause of death was unknown. The patient had been found dead at home, and the patient's wife called the team to notify them after the event. No autopsy was performed. The outcome was not considered device or therapy related. The device was not explanted. No further details were provided.

  Patient problems: Insufficient Information

  MAUDE report 50938323 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was admitted on (b)(6) 2026 with dark stools. It was said that event was anticoagulation related. An esophagogastroduodenoscopy (EGD), capsule study/colonoscopy was performed. The event did resolve with lower international normalized ratio (INR).

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 50937988 ↗
• MalfunctionSep 29, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937150 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Atrial Fibrillation; Atrial Flutter; Hemodynamic instability

  MAUDE report 50935340 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was diagnosed with proteus mirabilis Driveline infection on (b)(6) 2026 and was started on Keflex for 2 weeks. It was reported by the ventricular assist device (VAD) coordinators that the patient refused to wear anchors.

  Patient problems: Bacterial Infection

  MAUDE report 50934786 ↗
• InjurySep 29, 2026Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the Emergency Department (ED) on (b)(6) 2026 for new Driveline drainage and Modular Cable damage. When the patient attempted to connect to the HeartMate Touch System, it seemed that the System Controller would recognize that it was connected to a power source, but it would not upload any data. The customer tried to troubleshoot multiple times on two separate carts. The patient was not having any active alarms and reported no alarms at home. On interrogation, the System Controller showed 6 Low Voltage Advisory Alarms. There was a concern for a System Controller and/or Driveline Fault and both the Modular Cable and the System Controller were exchanged. Log Files were submitted after the exchanges were performed, as the customer was not able to interrogate the patient's original System Controller.

  Patient problems: Skin Infection

  MAUDE report 50931709 ↗
• DeathSep 29, 2026Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  It was reported the Pump was replaced on (b)(6) 2026. Post-operatively, the patient required ongoing mechanical ventilation, sedation and paralytics, with significant chest tube output, coagulopathy, and metabolic acidosis managed with blood products, protamine, and volume resuscitation. The patient developed abdominal compartment syndrome with bladder pressure of 40 mmHg, which led to an inability to achieve adequate left ventricular Assist Device (LVAD) or veno-venous extracorporeal membrane oxygenation (VV ECMO) flow. After extensive discussion with the family, the patient underwent emergent bedside exploratory laparotomy on (b)(6) 2026 with abdominal dressing placement, revealing viable bowel and significant serosanguinous fluid. There was initial improvement in both the LVAD and VV ECMO flows, but then the LVAD began to have low flows once again. Transesophageal echocardiogram (TEE) was completed at the bedside, concerning for right ventricular (RV) failure. After more discussion with the family, including risks, benefits, and alternatives, VV ECMO was converted to veno-pulmonary (VP) ECMO with percutaneous Right Ventricular Assist Device (RVAD) placement via right internal ju

  Patient problems: Coagulation Disorder; Compartment syndrome; Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding; Kidney injury; Respiratory Failure

  MAUDE report 50926938 ↗
• InjurySep 28, 2026Infusion or Flow Problem

  Patient problems: Obstruction/Occlusion

  MAUDE report 50924293 ↗
• DeathSep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away due to an unknown cause on (b)(6)2026.

  Patient problems: Insufficient Information

  MAUDE report 50924247 ↗
• DeathSep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient expired while on hospice. Log Files were not available. There were no alarms.

  Patient problems: Insufficient Information

  MAUDE report 50924176 ↗
• MalfunctionSep 28, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924162 ↗
• DeathSep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent aortic valve replacement. Following surgery, the patient went into hemorrhagic shock and passed away on (b)(6)2026. The Log files were not available. Autopsy will not be performed, and Pump will not be returned.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Valvular Insufficiency/ Regurgitation

  MAUDE report 50924042 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50923811 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50923763 ↗
• MalfunctionSep 28, 2026Infusion or Flow Problem

  Patient problems: Insufficient Information

  MAUDE report 50923673 ↗