THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) 106015Recalls & reported problems

Summary

The FDA's MAUDE database contains 8,000 adverse event reports that list this exact device (DI 00813024011224), received between Mar 16, 2018 and Sep 29, 2026 — classified as 2,141 deaths, 4,288 injuries, 1,571 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2,111 reports).

2 FDA recall records name this device's identifier, 2 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-0507-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Feb 19, 2024Class IOpen, Classified

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

   Z-1300-2024 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 8,000 reports, in the reporter's own words as published by the FDA.

• DeathSep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away due to an infection. There were no alarms associated with the event. Log Files were not available. The Pump was not explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50938367 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was diagnosed with a Driveline infection after a wound culture grew Candida parapsilosis on (b)(6) 2026. The patient was treated with micafungin and was transitioned to fluconazole on (b)(6) 2026 which would be continued when the patient was discharged. The patient was briefly on empiric vancomycin and cefepime but was stopped per transplant infectious disease (ID) recommendations. Cardiothoracic (CT) surgery was performed. Debridement was performed on (b)(6) 2026. The patient underwent another repeat washout on (b)(6) 2026 with micafungin bead placement, and a final washout on (b)(6) 2026 with wound vacuum assisted closure (VAC) placement. The patient was readmitted on (b)(6) 2026 due to pain at the VAC sponge and Driveline site. The patient remained admitted.

  Patient problems: Abdominal Pain; Fungal Infection; Skin Infection

  MAUDE report 50916340 ↗
• InjurySep 28, 2026Mechanical Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50915330 ↗
• MalfunctionSep 25, 2026Pumping Stopped

  It was reported that there was concern for potential Pump stop after the patient was placed on a Mobile Power Unit (MPU) several times. The patient verbalized frequent alarms during the event, but the alarms were unable to be seen on routine interrogation. Upon review of the submitted Log Files, routine events were observed, and a Pump stop was not able to be seen.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899451 ↗
• InjurySep 17, 2026Mechanical Problem; Infusion or Flow Problem

  Patient problems: High Blood Pressure/ Hypertension; Thrombosis/Thrombus

  MAUDE report 50811278 ↗
• DeathSep 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away due subdural hemorrhage after a fall at home.

  Patient problems: Fall; Hematoma; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Stroke/CVA

  MAUDE report 50747592 ↗
• MalfunctionSep 11, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740064 ↗
• InjurySep 4, 2026Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemodynamic instability; Insufficient Information

  MAUDE report 50619095 ↗
• MalfunctionSep 4, 2026Infusion or Flow Problem

  Patient problems: Heart Failure/Congestive Heart Failure; Hyperbilirubinemia; Lactate Dehydrogenase Increased; Swelling/ Edema; Tachycardia

  MAUDE report 50619067 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Arrhythmia

  MAUDE report 50598010 ↗
• MalfunctionAug 20, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50354433 ↗
• DeathAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away due to severe sepsis with shock and fluid collection adjacent to their Left Ventricular Assist Device (LVAD) Driveline (DL). The outcome was considered device/therapy related. An autopsy was not performed, and the Pump was not explanted.

  Patient problems: Abscess; Sepsis; Septic Shock; Skin Infection

  MAUDE report 50280679 ↗
• MalfunctionAug 11, 2026Mechanical Problem; Decreased Pump Speed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201838 ↗
• InjuryAug 4, 2026Mechanical Problem; Decreased Pump Speed; Infusion or Flow Problem

  It was reported that the Ventricular Assist Device (VAD) Coordinator saw one Power spike and 2 Low Flows on Left Ventricular Assist Device (LVAD) interrogation. The site was also inquiring if the patient would benefit from a clamshell repair. Log File review was requested which captured Low Flow Alarms on (b)(6) 2026. The Log File also captured transient Power and Flow elevations on (b)(6)2026. No other unusual events were noted. A slight tear to the Driveline was also noted. The Driveline appeared well covered with rescue tape and a clamshell repair would be scheduled in around a week. The patient was seen in clinic on (b)(6) 2026 with high Flow and Power beginning (b)(6) 2026. No alarms were reported, however occasional Low Voltage Advisory Alarms were noted. A Low-Speed Advisory was captured on (b)(6) 2026 while on Mobile Power Unit (MPU) power. Speed was noted at 8120 RPM with a Low-Speed limit of 8400 RPM. A upward shift in Pump Power (b)(6)2026 at 11:36 with Powers noted in the 6-7W range, the patient¿s baseline was around 4W. The patient's lab values were pending, and the patient had symptoms of dizziness with position changes. The patient had a hospitalization the week of (

  Patient problems: Dizziness

  MAUDE report 50131426 ↗
• InjuryJul 31, 2026Mechanical Problem; Infusion or Flow Problem

  It was reported that the Log Files were submitted to evaluate Power spikes. It appeared there were no unusual events recorded in the Log File Event history. The Mechanical Circulatory Support (MCS) equipment was operating as intended. The pump parameters trending showed Power and Flow trending upward with Pulsatility Index (PI) trending downward slightly. Per technical services, this trending could be suspect of Pump thrombus. On (b)(6) 2026, the patient was admitted for elevated Flows and Powers (>8). Computed tomography (CT) showed narrowing of Outflow Graft. Upon inspection in the cardiac catheterization laboratory, narrowing and gradient were not substantial enough for team to stent the Graft. During the procedure, Flows and Powers returned to normal, with Flows in the 4 liter per minute range (LPM) and Powers in 6's. Additional Log Files sent for review revealed that the Power went down from 8.6 Watts (W) to 6.1W and estimated Flow from 8.6LPM to 4.5LPM on 14 Jul 2026 at 15:13. Otherwise, there were no other notable alarm conditions or parameter changes in the Log File. The Ventricular Assist Device (VAD) was functioning as intended.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 50099844 ↗
• DeathJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away while on hospice care. It was unknown if the event was device or therapy related. The cause of death was not provided. The Pump was not explanted.

  Patient problems: Insufficient Information

  MAUDE report 50055652 ↗
• DeathJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2025. THE CAUSE OF DEATH WAS REPORTED TO BE FAILURE TO THRIVE.

  Patient problems: Insufficient Information

  MAUDE report 25473923 ↗
• DeathMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN AS THE PATIENT WAS FOUND AFTER A WELLNESS CHECK. THE LENGTH OF DEATH BEFORE BEING FOUND COULD NOT BE DETERMINED. THE PATIENT POSSIBLY HAD PUMP STOPS IN THE PAST AND DRIVELINE REPAIR. THE PATIENT WAS ON THE ORANGE CABLE AND WAS AT RISK OF FUTURE PUMP STOPS (2916596-2024-05262).

  Patient problems: Insufficient Information

  MAUDE report 25284282 ↗
• DeathApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN. THE PATIENT WAS WITH A FRIEND IN A CAR AND REPORTED NOT FEELING WELL. 1 MINUTE LATER THE FRIEND LOOKED OVER AND PATIENT'S HEAD DROPPED AND BODY SLOUCHED FORWARD AND THE PUMP BEGAN TO CONTINUOUSLY ALARM. 911 WAS CALLED AND IT WAS INDICATED THE PATIENT'S PUPILS WERE FIXED AND DILATED BY THE TIME EMERGENCY MEDICAL SERVICES (EMS) ARRIVED. EMS PERFORMED CARDIOPULMONARY RESUSCITATION (CPR) FOR 55 MINUTES WITHOUT ACHIEVING RETURN OF SPONTANEOUS CIRCULATION (ROSC). THE KIND OF ALARM WAS UNKNOWN AS BY THE TIME A VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR WAS CONTACTED, EMS HAD ALREADY PERFORMED CPR FOR 55 MINUTES, AND THE ALARM HISTORY WOULD HAVE BEEN OVERWRITTEN BY LOW FLOWS ASSOCIATED WITH EMS STOPPING CPR. THE SYSTEM CONTROLLER WAS DISPOSED AS IT WAS SOILED WITH BLOOD. THE PUMP WAS NOT EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24810983 ↗
• DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO BACTEREMIA. THE OUTCOME WAS NOT CONSIDERED DEVICE OR THERAPY RELATED. NO AUTOPSY WAS PERFORMED. THE PUMP WAS NOT EXPLANTED. THE DEVICE WAS OPERATING AS EXPECTED.

  Patient problems: Bacteremia

  MAUDE report 24735569 ↗
• DeathMar 30, 2026Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY AT (B)(6) ON (B)(6) 2026. THE HOSPITAL NOTIFIED OF PENDING PATIENT TRANSFER DUE TO NAUSEA AND VOMITING, ABDOMINAL PAIN, LOW FLOW ALARMS AND ALTERED MENTAL STATUS (AMS), HOWEVER THEIR FAMILY DECLINED TO TRANSFER AND DECIDED TO CHANGE THEIR CODE STATUS TO DO NOT RESUSCITATE (DNR)/ DO NOT INTUBATE (DNI).

  Patient problems: Abdominal Pain; Altered State of Consciousness; Nausea; Vomiting

  MAUDE report 24735508 ↗
• DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY.

  Patient problems: Insufficient Information

  MAUDE report 24716530 ↗
• DeathMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN (B)(6) 2026 DUE TO TRAUMATIC SUBDURAL HEMATOMA (SDH) AND SUBARACHNOID HEMORRHAGE (SAH) WHICH WAS LIKELY DUE TO A FALL THAT OCCURRED AT THEIR HOME. THE PATIENT¿S FAMILY DECIDED TO TRANSITION TO COMFORT MEASURES DUE TO THE PATIENT'S CONDITION CONTINUING TO DETERIORATE.

  Patient problems: Fall; Hematoma; Intracranial Hemorrhage

  MAUDE report 24702791 ↗
• DeathMar 20, 2026Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LOG FILES WERE SUBMITTED FOR REVIEW. THE LOG FILES CONTAINED A FEW PULSATILITY INDEX (PI) EVENTS AS WELL AS ROUTINE POWER SOURCE CHANGES. THE MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT OPERATED AS INTENDED. IT WAS LATER COMMUNICATED THAT THE PATIENT PASSED AWAY DUE TO A CATASTROPHIC INTRACEREBRAL HEMORRHAGE. AN ECHOCARDIOGRAM (ECHO) SHOWED AN EJECTION FRACTION OF 20-25%, RIGHT VENTRICULAR MILD DECREASED SYSTOLIC FUNCTION, MITRAL VALVE MILD MITRAL STENOSIS, AORTIC VALVE SUTURE CLOSED, AND PULMONIC VALVE TRACE REGURGITATION. THE COMPUTED TOMOGRAPHY (CT) RESULTS SHOWED A STABLE LARGE LEFT PARIETAL INTRAPARENCHYMAL HEMORRHAGE THAT INCLUDED APPROXIMATELY 4 TO 5 MM OF RIGHTWARD MIDLINE SHIFT. THE OUTCOME WAS NOT CONSIDERED TO BE DEVICE OR THERAPY RELATED AND OPERATED AS EXPECTED.

  Patient problems: Intracranial Hemorrhage; Mitral Valve Stenosis; Pulmonary Valve Insufficiency/ Regurgitation; Thrombosis/Thrombus

  MAUDE report 24651380 ↗
• DeathMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2026. THEY WENT HOME ON HOSPICE AND THE PATIENT STOPPED BREATHING. THE VENTRICULAR ASIST DEVICE (VAD) COORDINATOR WALKED THEM THROUGH TURNING OFF VAD. THE PATIENT HAD REFRACTORY VENTRICULAR TACHYCARDIA (VT), UNABLE TO BE FIXED WITH ABLATIONS AND MEDICATION. THEIR RIGHT VENTRICLE (RV) FAILED AND LEAD TO MULTISTAGE ORGAN FAILURE (MSOF). THIS WAS SAID TO BE NOT VAD RELATED AND THE VAD FUNCTIONING AS EXPECTED. THE VAD WAS NOT INTENDED TO BE RETURNED FOR ANALYSIS. IT WAS SAID THAT RV FAILURE WITH ARRHYTHMIA DID NOT EXIST PRE-IMPLANT.

  Patient problems: Heart Failure/Congestive Heart Failure; Multiple Organ Dysfunction Syndrome; Tachycardia

  MAUDE report 24651171 ↗