THORATEC® HEARTMATE II®, LVAS IMPLANT KIT 107801Recalls & reported problems

Summary

The FDA's MAUDE database contains 721 adverse event reports that list this exact device (DI 00813024011996), received between Jun 11, 2018 and Sep 24, 2026 — classified as 217 deaths, 362 injuries, 142 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (190 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-0508-2026 · 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 721 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Bacterial Infection; Skin Infection

  MAUDE report 50886641 ↗
• InjuryJul 27, 2026Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that the article ¿Outcome of ventricular assist devices in adults with congenital heart disease ¿ A single center case series¿ was a single-center retrospective cohort study of patients who underwent ventricular assist device (VAD) implantation at the Mayo Clinic between 2003 and 2023. The study described the clinical characteristics and post-operative outcomes of the cohort, while assessing post-operative temporal changes in end-organ biomarkers and hemodynamic indices. Given the high mortality rate of advanced heart failure in adults with congenital heart disease (CHD), the investigation aimed to evaluate if VAD therapy provides an acceptable palliation or bridge to transplantation despite potential long-term survival limitations. Data on specific indices, including N-terminal pro-hormone brain natriuretic peptide (NT-proBNP), the model for end-stage liver disease excluding international normalized ratio (MELD-XI), right atrial pressure, and non-systemic ventricular systolic pressure, were tracked pre-implantation and 30 days post-implantation.Of the 11 patients who met the criteria for VAD implantation between January 2009 and December 2022 (median age 42 years,

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

  MAUDE report 50011808 ↗
• DeathApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE PATIENT PASSED AWAY DUE TO INTERCRANIAL HEMORRHAGE. THE DEVICE PARAMETERS WERE WITHIN NORMAL LIMITS. THE OUTCOME WAS NOT CONSIDERED DEVICE OR THERAPY RELATED. THE PUMP WAS NOT EXPLANTED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 24945198 ↗
• InjuryFeb 12, 2026Infusion or Flow Problem

  IT WAS REPORTED THE PATIENT WAS BEING FOLLOWED CLOSELY FOR OUTFLOW GRAFT STENOSIS. A FOLLOW UP COMPUTERIZED TOPOGRAPHY WAS PLANNED, BUT NO SURGICAL INTERVENTION WAS PLANNED. THERE WERE NO CHANGES TO PATIENT CONDITION, ANTICOAGULATION, OR PUMP PARAMETERS THAT MAY HAVE CONTRIBUTED. STENOSIS WAS CONFIRMED VIA ECHOCARDIOGRAM AND CT. DYSPNEA ON EXERTION (DOE) WAS NOTED. BLOOD PRESSURE CONTROL WAS PERFORMED.

  Patient problems: Dyspnea

  MAUDE report 24328907 ↗
• DeathFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO A RECURRING DRIVELINE INFECTION (MFR# 2916596-2025-03427).

  Patient problems: Bacterial Infection; Skin Infection

  MAUDE report 24272652 ↗
• MalfunctionFeb 4, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC WITH A DRIVELINE TEAR NEAR WHERE IT CONNECTS TO THE SYSTEM CONTROLLER. RESCUE TAPE WAS PLACED OVER IT TO TEMPORARILY REINFORCE. A CLAMSHELL REPAIR WAS COMPLETED. THERE WERE NO ALARMS ASSOCIATED WITH THE DRIVELINE TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259881 ↗
• MalfunctionDec 19, 2025Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT WAVEFORMS WERE SENT TO CAPTURE DRIVELINE FAULT ALARMS WHILE PATIENT WAS HOSPITALIZED. THE PATIENT WAS VISITING AND WOULD FOLLOW UP WITH THE IMPLANTING CENTER. THE LOG FILE CAPTURED INTERMITTENT DRIVELINE FAULT EVENTS THROUGHOUT THE LOG. PHASE DATA SHOWED MONITORED WIRE OF PHASE 1 (GREEN) HAVING SOME CONTINUITY ISSUES THAT DID NOT LOOK COMPLETELY BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848924 ↗
• MalfunctionNov 6, 2025Mechanical Problem; Pumping Stopped; Mechanical Problem; Pumping Stopped

  IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR A PATIENT WHO PRESENTED TO THE CLINIC WITH LOW VOLTAGE ALARMS WHEN PATIENT WAS ATTACHED TO THEIR MOBILE POWER UNIT (MPU). THE SITE ALSO OBSERVED A DRIVELINE FAULT ON INTERROGATION. PATIENT HAS A HISTORY OF PERCUTANEOUS LEAD REPAIR IN 2017, AND A CLAMSHELL APPLIED IN 2022. THEIR DRIVELINE WAS HEAVILY BURDENED WITH RESCUE TAPE. THE DATA FROM THE LOG FILE SHOWED SPEED REDUCTION AND PUMP STOPPED EVENTS ON (B)(6) 2025. THESE ISSUES ONLY APPEARED TO BE OCCURRING WHILE THE DEVICE WAS CONNECTED TO THE MPU POWER. THIS TYPE OF BEHAVIOR HAS BEEN LINKED TO POTENTIAL ISSUES WITH THE PERCUTANEOUS LEAD, AND IT WAS RECOMMENDED TO KEEP THE DEVICE CONNECTED TO BATTERY POWER OR AN UNGROUNDED PATIENT CABLE AND POWER MODULE UNTIL FURTHER INVESTIGATION IS COMPLETED TO PREVENT FURTHER INTERRUPTION IN SUPPORT. THE PATIENT WAS ADMITTED (B)(6) 2025. THEY HAD A KNOWN NARROWING OF OFG AND THE SITE WAS INTENDING TO LOOK AT THIS FIRST BEFORE MAKING A DECISION ABOUT EXTERNAL DRIVELINE REPAIR OR NEED FOR EXCHANGE. WHILE ADMITTED, THE PATIENT EXPERIENCED A PUMP STOP EVENT ON (B)(6) 2025 AT 5:18 THAT FROM LOG FILE ANALYSIS APPEARED TO BE A SHORT-TO-SHIELD EVENT. IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493305 ↗
• MalfunctionOct 29, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2025 NIGHT. HE HAD A HEARTMATE 2. WHILE INTERROGATING THE PATIENT'S ALARM HISTORY ON THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) MONITOR ON (B)(6) 2025 MORNING, THE MONITOR SCREEN SHOWED DRIVELINE FAULT ALARM. THERE WAS NO ACTIVE ALARM ON THE SYSTEM CONTROLLER. THE DRIVELINE FAULT ALARM ON THE MONITOR WENT AWAY WHILE STILL LOOKING AT THE HISTORY. UPON REVIEW OF ALARM HISTORY, IT WENT BACK ON (B)(6) 2025. THE PATIENT HAD 1 DRIVELINE FAULT ALARM ON (B)(6) 2025, 2 DRIVELINE FAULT ALARMS ON (B)(6) 2025, AND ON (B)(6) 2025 THE PATIENT HAD MULTIPLE DRIVELINE FAULT ALARMS. THE PATIENT DENIED HEARING ANY ALARMS OR SEEING ANY YELLOW WRENCH ALARMS ANYTIME RECENTLY. THERE WERE RARE SYSTEM INFORMATION ALARMS ON HISTORY. NO OTHER RANDOM ALARMS WERE NOTED. THERE WAS A PATTERN OF LOW BATTERY THAT SUGGESTED THE PATIENT MIGHT HAVE SLEPT ON BATTERY. THE PATIENT ADMITTED TO SLEEPING ON BATTERIES AND WAS REEDUCATED ON THE RECOMMENDATIONS AND DANGERS OF SLEEPING ON BATTERY AND NOT MOBILE POWER UNIT (MPU). THE PATIENT DID HAVE RESCUE TAPE ALL DOWN THEIR DRIVELINE. IT WAS STRANGE THAT THE MONITOR WAS ACTIVELY SHOWING DRIVELINE FAULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417472 ↗
• MalfunctionOct 24, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT HAD A NARROWING OF THE OUTFLOW GRAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stenosis

  MAUDE report 23383232 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ON A LOWER ANTICOAGULATION GOAL OF 1.5 TO 2 DUE TO A HISTORY OF GASTROINTESTINAL BLEEDING (GIB) THAT STARTED POST-IMPLANTATION IN 2018. IT HAS SINCE RESOLVED, AND THE PATIENT WOULD RECEIVE MONTHLY OCTREOTIDE INJECTIONS AND THEIR HEMOGLOBIN AND HEMATOCRIT LEVELS WOULD BE MONITORED. THIS INFORMATION WAS PREVIOUSLY REPORTED UNDER MFR# 2916596-2025-04888.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 23280520 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A COMPUTED TOMOGRAPHY (CT) ON (B)(6) 2024 OF THE ABDOMEN AND PELVIS SHOWED A NORMAL-APPEARING DRIVELINE COARSE, AND NO SPECIFIC FINDING TO INDICATE INFECTION. NEW ENLARGEMENT OF THE RECTUS SHEATH MUSCULATURE WAS SEEN IN THE RIGHT LOWER QUADRANT MEASURING 7 X 4 X 7 CM WITH INTERNAL COMPLEX FLUID DENSITY, NO ACUTE BLOOD PRODUCTS WERE NEEDED. THE FINDING WAS DETERMINED TO LIKELY REPRESENT A POSTOPERATIVE SEROMA. ON (B)(6) 2024 THE SITE NOTED THAT THE RESULTS WERE CONCERNING. A FOLLOW UP CT OF THE ABDOMEN AND PELVIS SHOWED DEHISCENCE OF THE VERTICAL LOWER VENTRAL ABDOMINAL WALL SKIN STAPLES. ILL-DEFINED FLUID COLLECTION DEEP TO THE ANTERIOR ABDOMINAL WALL DEFECT MEASURING 1 X 4.3 X 3.4 CM. THE FINDING LIKELY REPRESENTED A HEMATOMA OR SEROMA. IT WAS NOTED THAT AN INFECTED COLLECTION COULD NOT BE EXCLUDED ON THE BASIS OF THIS EXAMINATION. NONSPECIFIC STRANDING WITHIN THE VENTRAL ABDOMINAL WALL AND SKIN THICKENING WAS OBSERVED, SIMILAR TO PRIOR STUDY AND MAY BE POSTPROCEDURAL CHANGES. CELLULITIS WAS NOTED TO POTENTIALLY HAVE A SIMILAR IMAGING. ON (B)(6) 2024 THE RESULTS REMAINED ABNORMAL. ENLARGEMENT OF VENTRAL WALL ABDOMINAL WALL POSTOPERATIVE WOUND DEHISCENCE BUT NO

  Patient problems: Bacterial Infection; Hematoma; Seroma; Skin Infection; Unspecified Infection; Wound Dehiscence

  MAUDE report 23074800 ↗
• MalfunctionSep 16, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) ON (B)(6) 2025 WHERE ECCENTRIC FILLING DEFECT WITHIN THE OUTFLOW CANNULA SUSPICIOUS FOR THROMBUS WAS DETECTED. THERE WAS NONOCCLUSIVE THROMBUS WITHIN THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) OUTFLOW.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23065203 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LOG FILES WERE SUBMITTED FROM (B)(6) 2025 AS THE PATIENT WAS ADMITTED WITH FLUID OVERLOAD. IT APPEARED THAT THE VAD AND PERIPHERAL EQUIPMENT FUNCTIONED AS INTENDED.

  Patient problems: Chest Pain; High Blood Pressure/ Hypertension; Hypervolemia; Skin Infection; Unspecified Infection

  MAUDE report 23042925 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSPLANT. WHETHER THE DEVICE WOULD BE RETURNED, AND THE OUTCOME WAS DEVICE OR THERAPY RELATED, WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22960223 ↗
• MalfunctionAug 25, 2025Mechanical Problem; Decreased Pump Speed; Mechanical Problem; Decreased Pump Speed

  IT WAS REPORTED THAT LOG FILES WERE SENT FOR REVIEW. THE LOG CAPTURED MULTIPLE LOW SPEED ADVISORIES ON (B)(6) 2025 AND (B)(6) 2025 WHILE THE PATIENT WAS CONNECTED TO WALL POWER. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT HAD OPERATED AS INTENDED. TECH SERVICES WERE ON SITE ON (B)(6) 2025 AND PERFORMED A SHORT TO SHIELD DRIVELINE REPAIR. THE SPLICE WAS APPROXIMATELY 3 INCHES FROM THE EXIT SITE. THE EXCISED DRIVELINE WAS SHIPPED FOR AN URGENT ANALYSIS. THE PATIENT USED AN UNGROUNDED PATIENT CABLE AND WOULD REMAIN IN THE HOSPITAL AND ON THE CABLE UNTIL ANALYSIS WAS COMPLETED. ADDITIONAL LOG FILES WERE SENT FOR REVIEW. THE LOG FILE CAPTURED THE EVENTS FROM THE DRIVELINE REPAIR ON (B)(6) 2025 AT 17:21. SINCE THAT TIME THERE HAD BEEN NO FURTHER LOW SPEED OR PUMP OFF EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890608 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO AN ALTERNATIVE HOSPITAL FOR A HEART TRANSPLANT.

  Patient problems: Insufficient Information

  MAUDE report 22890575 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE PATIENT UNDERWENT A ROUTINE HEART TRANSPLANT. REGARDING TRANSPLANT PROCEDURES IN JAPAN, CURRENTLY, THERE IS NO RULE FOR TRANSPLANT DUE TO DEVICE MALFUNCTION OR SECONDARY FACTORS. THERE HAD BEEN NO REPORTS OF PROBLEMS WITH THE DEVICE OPERATING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522860 ↗
• MalfunctionJul 15, 2025Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ALARM APPEARED TO HAVE CLEARED FOLLOWING THE CONTROLLER EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509911 ↗
• DeathJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD WEAKNESS, LETHARGY, SHORTNESS OF BREATH, AND LIGHTHEADEDNESS IN THE SETTING OF PULMONARY EMBOLISM AND PNEUMONIA WITH SUBSEQUENT TRANSITION TO COMFORT CARE AT THE PATIENT'S REQUEST. THE PATIENT PASSED AWAY ON COMFORT CARE. THE OUTCOME WAS NOT CONSIDERED DEVICE OR THERAPY RELATED. AN AUTOPSY WAS NOT PERFORMED. THE DEVICE WAS NOT EXPLANTED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Dizziness; Dyspnea; Lethargy; Muscle Weakness/Atrophy; Pneumonia; Pulmonary Embolism

  MAUDE report 22508687 ↗
• MalfunctionJul 14, 2025Decreased Pump Speed; No Apparent Adverse Event; Decreased Pump Speed; No Apparent Adverse Event

  A LOW SPEED ADVISORY WAS NOTED ON (B)(6) 2025 AT 03:34 WITH SPEED NOTED AT 7930 RPM. THE LOG FILE CAPTURED SYSTEM CONTROLLER EXCHANGE OR IMPLANT DATA, AND INDICATED THAT SOMETHING MAY HAVE PASSED THROUGH THE PUMP CAUSING THE LOW SPEED ADVISORY. ADDITIONAL LOG FILES WERE SUBMITTED ON (B)(6) 2025 WHICH REVEALED NO FURTHER UNUSUAL EVENTS IN THE LOG FILE EVENT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500448 ↗
• InjuryJul 11, 2025Mechanical Problem; Decreased Pump Speed; Infusion or Flow Problem; Mechanical Problem; Decreased Pump Speed; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PUMP EXCHANGE ON (B)(6) 2025. THE PATIENT RECEIVED AN EMERGENT EXCHANGE ON (B)(6) 2025 FOR SUSPECTED THROMBUS. THE PATIENT'S LOG FILES WERE SUBMITTED FOR REVIEW. ON (B)(6) 2025, THE FILE CAPTURED INTERMITTENT FLOW/POWER ELEVATIONS. RELATED MANUFACTURER REPORT NUMBER 2916596-2025-01292 DOCUMENTS THE PUMP BEING TURNED OFF.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22480603 ↗
• MalfunctionJul 8, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD A KNOWN DRIVELINE FAULT AND LOG FILES WERE SENT FOR REVIEW. THERE WERE NO CHANGES IN PATIENT CLINICAL STATUS AND NO ACUTE CONCERNS. THE LOG FILE CONTAINED THE REPORTED ONGOING DRIVELINE FAULTS. THE PUMP APPEARED TO BE MAINTAINING THE SET SPEED AND OPERATING WITHIN NORMAL PARAMETERS. THE LOG FILE ALSO CONTAINED MULTIPLE LOW FLOW HAZARD EVENTS. THE FLOW READINGS DID NOT APPEAR TO BE THE RESULT OF ANY EXTERNAL EQUIPMENT MALFUNCTION. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439243 ↗
• MalfunctionJun 27, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED LOWER FLOW READINGS AND THE COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A NARROWING AREA IN THE OUTFLOW GRAFT. THE HEALTHCARE PROVIDERS WERE STILL DISCUSSING THE DIFFERENT OPTIONS AND THE PATIENT WAS PLACED ON THE SUPER URGENT TRANSPLANT LIST. THE PATIENT REMAINED ON THE URGENT HEART TRANSPLANT LIST. THE PATIENT WAS STABLE AND HAD NOT HAD ANY SEVERE CLINICAL SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350210 ↗
• InjuryJun 17, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A SUSPECTED PUMP THROMBUS. LOG FILES WERE SENT FOR REVIEW. THE EVENT LOG CAPTURED ROUTINE EVENTS. THE VENTRICULAR ASSIST DEVICE (VAD) AND PERIPHERAL EQUIPMENT APPEARED TO HAVE FUNCTIONED AS INTENDED. A SPEED CHANGE WAS NOTED BACK ON (B)(6) 2025 FROM 9400 TO 9800 REVOLUTIONS PER MINUTE (RPM). THERE WAS ALSO ELEVATED LACTATE DEHYDROGENASE (LDH), AMBER URINE, AND AN ABNORMAL RAMP/RPM ECHOCARDIOGRAM (ECHO).

  Patient problems: Lactate Dehydrogenase Increased; Thrombosis/Thrombus

  MAUDE report 22235793 ↗