THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) 104911Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,092 adverse event reports that list this exact device (DI 00813024011170), received between Jun 11, 2018 and Sep 25, 2026 — classified as 451 deaths, 463 injuries, 178 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (188 reports).

1 FDA recall record name this device's identifier, 1 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. 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 1,092 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50901225 ↗
• DeathSep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50901141 ↗
• DeathSep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away due to heart failure. Whether the outcome was device or therapy related was not provided by the customer.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50841723 ↗
• DeathAug 27, 2026Disconnection; Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's wife found the patient down and disconnected form their power source with no alarms active at the time. The patient's wife stated that she was sleeping in a different room and never heard any alarms. She believed the patient was possibly getting up for the restroom, got confused and could not get themselves on Batteries properly. The patient passed away. Log Files were sent for review and captured the Driveline disconnect and the Pump not operating. The Driveline was disconnected on (b)(6) 2026 at 10:30. The Pump operated at he set speed for the remainder of the Log File which ended on (b)(6) 2026 at 4:18 with Low Battery Advisory and Hazard events. It was unknown if the device would be returned for evaluation.

  Patient problems: Insufficient Information

  MAUDE report 50484244 ↗
• DeathAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away due to failure to thrive, progressive renal failure, and systolic and diastolic heart failure. The death was considered to be device/therapy related. The Pump was not explanted, and the device parameters were stated to be within normal limits for the patient.

  Patient problems: Heart Failure/Congestive Heart Failure; Renal Failure

  MAUDE report 50277091 ↗
• MalfunctionJan 2, 2026Mechanical Problem

  IT WAS REPORTED THAT A CLAMSHELL REPAIR WAS PERFORMED WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950054 ↗
• DeathDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2025 TO (B)(6) 2025 WITH GASTROINTESTINAL BLEEDING (GIB). ESOPHAGOGASTRODUODENOSCOPY (EGD)/COLONOSCOPY WAS UNABLE TO FIND THE SOURCE, BUT HEMOGLOBIN CONTINUED TO TREND DOWNWARD EVEN WITH BLOOD TRANSFUSIONS. THE PATIENT PASSED AWAY AT HOME WHILE ON HOSPICE ON (B)(6) 2025 AT 14:05. THE OUTCOME WAS NOT CONSIDERED TO BE DEVICE RELATED. THE OUTCOME WAS RELATED TO GIB SECONDARY TO ANTICOAGULATION AND VENTRICULAR ASSIST DEVICE (VAD) SUPPORT. THE DEVICE PARAMETERS WERE WITHIN NORMAL LIMITS FOR THIS PATIENT.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 23759662 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD LOW HEMOGLOBIN AND HEMATOCRIT. IT WAS SAID THE PATIENT HAD BLOOD TRANSFUSIONS. THEY ALSO HAD AN INCISION AND DRAINAGE AS WELL. THE BLOOD TRANSFUSION IMPROVED THE LOW HEMOGLOBIN AND HEMATOCRIT. THE ONSET OF THE INFECTION WAS (B)(6) 2022 (THE ONSET OF THE INFECTION IS COVERED UNDER MANUFACTURER REPORT NUMBER: 2916596-2023-05254). THE PATIENT HAD FATIGUE, AND THE SOURCE OF THE INFECTION WAS PUMP POCKET. DRAINAGE AND METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) WAS IDENTIFIED. THE INFECTION WAS BEING TREATED WITH ERTAPENEM INTRAVENOUS AND WAS NOT RESOLVED. IT WAS PLANNED TO CONTINUE TREATING THE PATIENT WITH ERTAPENEM INTRAVENOUS.

  Patient problems: Drug Resistant Bacterial Infection; Fatigue; Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 23451212 ↗
• MalfunctionOct 15, 2025Disconnection; Electrical /Electronic Property Problem; Disconnection; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR REVIEW WHICH CAPTURED DRIVELINE DISCONNECT ALARMS ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294429 ↗
• InjurySep 30, 2025Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNOWN OUTFLOW THROMBUS SINCE (B)(6) 2023. THE OUTFLOW THROMBUS WAS INITIALLY IDENTIFIED THROUGH A ROUTINE ECHOCARDIOGRAM (ECHO). AN ECHO AND A GATED COMPUTED TOMOGRAPHY (CT) WERE USED AT THE TIME FOR DIAGNOSTIC TESTING. THE PATIENT WAS BRIEFLY PLACED ON HEPARIN. LOG FILES WERE NOT AVAILABLE FROM THE ORIGINAL EVENT IN 2023.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23183783 ↗
• MalfunctionSep 28, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CUSTOMER SUBMITTED IMAGES OF THE DRIVELINE OUTER LAYER DAMAGE COVERED BY RESCUE TAPE. THE DRIVELINE SEEMED EXTREMELY FRAGILE, PAPER THIN LIKE, AND WITH MULTIPLE AREAS OF SMALL TEARS THAT REQUIRED RESCUE TAPE. THE IMAGES SUBMITTED SHOWED AREAS THAT APPEARED TO HAVE EXISTING AREAS COVERED BY RESCUE TAPE. LOG FILES WERE SENT FOR REVIEW. THE LOG FILE DATA SHOWED NO INDICATIONS OF CONDUCTOR WEAR OR DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23163976 ↗
• InjurySep 23, 2025Mechanical Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  FROM ECHOCARDIOGRAM (ECHO) DONE ON (B)(6) 2025, IT WAS SAID AN ULTRASOUND ENHANCING AGENT WAS USED. THE HEARTMATE II LVAD SETTINGS AT THE TIME OF THIS EXAM WERE THAT THE PUMP SPEED WAS AT 10,000 RPM, FLOW RATE WAS AT 5.5 L/MIN, PULSE INDEX WAS AT 5.3, POWER WAS AT 6.6 W. THE LEFT VENTRICULAR CHAMBER SIZE AND WALL THICKNESS WERE NORMAL. LEFT VENTRICULAR CHAMBER SIZE AND WALL THICKNESS ARE NORMAL. THE LEFT VENTRICULAR INTERNAL DIAMETER (LVID) WAS 5.6CM. THERE WAS NO LEFT VENTRICULAR THROMBUS SEEN ON THE CONTRAST ENHANCED IMAGES. THE LEFT VENTRICULAR SYSTOLIC FUNCTION WAS SEVERELY REDUCED WITH A VISUALLY ESTIMATED EJECTION FRACTION OF 10%. THERE WAS NO OBVIOUS OBSTRUCTION, SEPTAL SUCTIONING, OR THROMBUS AT THE VENTRICULAR ASSIST DEVICE (VAD) INFLOW CANNULA. THE RIGHT VENTRICLE WAS DILATED WITH GROSSLY NORMAL SYSTOLIC FUNCTION BY VISUAL ASSESSMENT IN LIMITED VIEWS. WITH THE LVAD IN PLACE, THE AORTIC VALVE OPENED MINIMALLY (ONLY SEEN IN SHORT AXIS) WITH EVERY CARDIAC CYCLE WITH TRACE REGURGITATION. THERE WAS MILD TRICUSPID VALVE REGURGITATION. THERE WAS NO PULMONARY HYPERTENSION AND THE ESTIMATED PULMONARY ARTERIAL SYSTOLIC PRESSURE WAS 23 MMHG. PERICARDIUM WAS NORMAL IN APPEARANCE WIT

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Pulmonary Valve Insufficiency/ Regurgitation; Thrombosis/Thrombus; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23126681 ↗
• DeathJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY FROM A COMBINATION OF PSEUDOMONAS INFECTION, ACUTE KIDNEY INJURY, ENCEPHALOPATHY, AND FAILURE TO THRIVE.

  Patient problems: Bacterial Infection; Encephalopathy; Kidney injury

  MAUDE report 22645675 ↗
• MalfunctionJul 17, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN NEED OF A NON-URGENT ¿WIRE SURGERY.¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534722 ↗
• DeathJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH PATIENT OUTCOME THAT THE PATIENT PASSED AWAY.

  Patient problems: Insufficient Information

  MAUDE report 22522024 ↗
• DeathJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO NATURAL CAUSES. THE OUTCOME WAS NOT CONSIDERED TO BE DEVICE OR THERAPY RELATED. THE DEVICE WOULD NOT BE EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 22289934 ↗
• DeathJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO END STAGE HEART FAILURE. THE PATIENT WAS ON HOSPICE. ADDITIONAL DETAILS LEADING UP TO DEATH WERE UNKNOWN. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED. THE DEVICE OPERATED AS EXPECTED. NO DEVICE WOULD BE RETURNED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22177072 ↗
• DeathJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN. WHETHER THE OUTCOME WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED BY THE CUSTOMER. THE PUMP WOULD NOT BE EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 22160201 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A STERNAL WOUND WITH ABSCESS. THE CULTURE WAS ESCHERICHIA COLI. THEY RETURNED TO OPERATING ROOM FOR DEBRIDEMENT. AT THE TIME, THEY HAD A WOUND VAC IN PLACE. THE PATIENT REMAINED CHRONIC ANTIBIOTICS. HEALTHCARE PLANNED TO CONTINUE TO MONITOR. THE PATIENT WAS ADMITTED FROM (B)(6) 2025.

  Patient problems: Abscess; Bacterial Infection

  MAUDE report 22136258 ↗
• InjuryMay 23, 2025Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH REPORTS OF PROFOUND SHORTNESS OF BREATH AND EXERTIONAL DYSPNEA STATING THEY FELT LIKE HOW THEY DID BEFORE THEIR IMPLANT. ECHOCARDIOGRAM IMAGES AND COMPUTED TOMOGRAPHY ANGIOGRAPHY WERE TO FOLLOW, BUT THE PATIENT HAD A KNOWN OUTFLOW GRAFT OBSTRUCTION THAT WAS SUSPECTED TO BE WORSENING. LOG FILES WERE SENT FOR REVIEW TO DIVULGE ANY APPRECIABLE TRENDS IN POWER OR FLOW OVER TIME. THE LOG FILES COULD CAPTURE A SPEED INCREASE TO OVERCOME THE OBSTRUCTION. THE BASELINE SPEED WAS NOTED TO BE 10000. NO ALARMS WERE FOUND ON INTERROGATION. THE PATIENT HAD SUSPICIOUS PULSATILITY INDEX (PI) EVENTS IN THE HISTORY. THE LOG FILE CAPTURED ROUTINE EVENTS THROUGHOUT THE LOG FILE. THE VENTRICULAR ASSIST DEVICE (VAD) PARAMETERS LOOKED STABLE OVERALL, THERE WERE A FEW BLIPS OF HIGH POWER IN THE 9W RANGE ON (B)(6) 2025, WHICH WERE NOT SUSTAINED AND ALSO ASSOCIATED WITH PI EVENTS. THE PATIENT UNDERWENT A SURGICAL REPAIR FOR THE OUTFLOW GRAFT OBSTRUCTION ON (B)(6) 2025.

  Patient problems: Dyspnea; Hemolysis; Lactate Dehydrogenase Increased; Thrombosis/Thrombus

  MAUDE report 22079715 ↗
• DeathApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE AORTIC ANEURYSM WAS GENETIC IN ORIGIN. THERE WAS NO DEVICE INVOLVEMENT IN THE PATIENT'S DEATH AND THE DEVICE OPERATED AS EXPECTED.

  Patient problems: Ruptured Aneurysm

  MAUDE report 21901847 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT VENTRICULAR ASSIST DEVICE (LVAD) RELATED PARA-DEVICE SOFT TISSUE INFECTION SINCE (B)(6) 2024. THE PATIENT HAD AN LVAD DRIVELINE WOUND PUS DISCHARGE LEADING TO RE-HOSPITALIZATION FOR INFECTION SURVEY AND THE PATIENT WAS STABLE. THE PATIENT HAD SYMPTOMS OF PUS DISCHARGE AT THE DRIVELINE WOUND AND THE PATIENT FELT PAIN AT THE WOUND AREA. A COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED TISSUE INFECTION AROUND THE LVAD DEVICE POCKET. THE PUS CULTURE FOUND PROTEUS MIRABILIS AND ACHROMOBACTER SPP. THE PATIENT WAS TREATED WITH ORAL MOXIFLOXACIN AND THEN DISCHARGED. ON (B)(6) 2025 THE PATIENT UNDERWENT A HEART TRANSPLANT. THIS WAS DEVICE OR THERAPY RELATED. THE HEART TRANSPLANT RESOLVED THE INFECTION AND THE DRIVELINE WOUND HEALED. THE DEVICE OPERATED AS EXPECTED. THE EVENT DATE WAS ESTIMATED AND THE EXACT DATE WAS NOT PROVIDED.

  Patient problems: Bacterial Infection; Pain; Purulent Discharge; Skin Infection

  MAUDE report 21755906 ↗
• DeathMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO SEPSIS AND VENTRICULAR TACHYCARDIA.

  Patient problems: Sepsis; Tachycardia

  MAUDE report 21518017 ↗
• DeathJan 23, 2025Mechanical Problem; Mechanical Problem

  THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ELEVATED LACTATE DEHYDROGENASE (LDH) LEVELS, HEMATURIA, AND POWER ELEVATIONS. BIVALIRUDIN WAS INITIATED AND THE PATIENT'S NUMBERS NORMALIZED; HOWEVER, WHEN BIVALIRUDIN WAS DISCONTINUED, LDH BEGAN TO RISE AND HEMATURIA OCCURRED. IT WAS REPORTED THAT THE SURGICAL PLACEMENT OF THE ORIGINAL PUMP WAS DIFFICULT. THE PUMP WAS SUBSEQUENTLY EXCHANGED AND THE HOSPITAL REPORTED THAT THEY PLUGGED THE OLD SITE USING A FELT PLUG AND RE-CORED THE HEART. A THROMBUS WAS SEEN ON THE OUTFLOW STATOR BLADES. ADDITIONAL INFORMATION PROVIDED TO THE MANUFACTURER INDICATED THAT THE HEART WAS RE-CORED BECAUSE THE HOSPITAL FELT THAT THE INFLOW WAS MALPOSITIONED AND WAS POTENTIALLY COMPROMISING FLOW. A DEVICE TRACKING FORM WAS RECEIVED INDICATING THAT THE PATIENT EXPIRED ON (B)(6) 2014 APPROXIMATELY 1 MONTH AFTER THE PUMP EXCHANGE. THE CAUSE OF DEATH WAS NOTED TO BE A MIDDLE CEREBRAL ARTERY (MCA) CEREBROVASCULAR ACCIDENT (CVA) DUE TO VAD THROMBUS. IT WAS REPORTED THAT ANTICOAGULATION LIKELY CONTRIBUTED TO THE STROKE. THE SECOND PUMP WAS REPORTED TO BE FUNCTIONING AS INTENDED AND NO DEVICE IS

  Patient problems: Hematuria; Hemolysis; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 21217204 ↗
• DeathJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY AND THE CAUSE WAS UNKNOWN. THE OUTCOME WAS NOT DEVICE OR THERAPY RELATED. AN AUTOPSY WAS NOT PERFORMED AND WOULD NOT BE PROVIDED. THE PUMP WAS NOT EXPLANTED AND WOULD NOT BE RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 21067292 ↗