Thoratec® HeartMate 3™ 106531LF2Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05415067031105), received between Jan 4, 2021 and Sep 4, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

17 other recalls cover devices cleared under the same FDA submission (P160054); they may or may not involve this specific model.

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. 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 ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Disconnection; Mechanical Problem; Improper or Incorrect Procedure or Method; Disconnection; Mechanical Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE LOW VOLTAGE ADVISORY ALARMS. THE PATIENT HAD RESCUE TAPE ON THEIR MODULAR CABLE NEAR THE DRIVELINE SECTION DUE TO PAST EXPOSED WIRE DAMAGE BUT HAD NOT HAD A MODULAR CABLE EXCHANGE DUE TO THEIR CURRENT HEALTH STATUS OF END STAGE RIGHT VENTRICULAR HEART FAILURE. THEY WERE BEING TREATED WITH IV MILRINONE AND NO ANTICOAGULATION. LOG FILES WERE SUBMITTED FOR REVIEW. THE LOG FILE CAPTURED NUMEROUS ODD LOW POWER ADVISORIES AND POWER CABLE DISCONNECTS WHILE THE PATIENT WAS CONNECTED TO THE MOBILE POWER UNIT (MPU). A LOANER MPU WAS GIVEN AND USED FOR THE PAST WEEK. LOG FILES WERE THEN SENT FOR REVIEW ON 12AUG2025 BECAUSE THE PATIENT CONTINUED TO HAVE LOW VOLTAGE/ NO EXTERNAL POWER ALARMS. PER TECHNICAL SERVICES, ALL OF THE LOW POWER EVENTS WERE DUE TO NORMAL BATTERY DEPLETION. THE LATEST DATA DID NOT CONTAIN ANY NO EXTERNAL POWER EVENTS ALTHOUGH THERE WAS SOME ODD POWER CABLE DISCONNECTS. THE SYSTEM CONTROLLER WAS A REV 1.5.2 AND WAS AROUND 5 YEARS OLD. DUE TO THE ODD POWER CABLE DISCONNECTS AND THE REPORTED DAMAGE TO THE CONTROLLER WHITE LEAD, A CONTROLLER REPLACEMENT WAS RECOMMENDED WHEN/IF THE PATIENT WAS ABLE TO TOLERATE A PUMP STOP ASSOCIAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965402 ↗
• MalfunctionAug 7, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT CUSTOMER RECEIVED LOW FLOW CONTROLLER WITH A BROKEN EMERGENCY BACKUP BATTERY (EBB) DOOR SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742766 ↗
• MalfunctionJul 16, 2025Disconnection; Electrical Power Problem; Complete Loss of Power; Disconnection; Electrical Power Problem; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT REPORTED BACKUP BATTERY FAULT, BUT NONE WERE SEEN ON INTERROGATION. WHEN LOOKING THROUGH MEMORY ON THE SYSTEM CONTROLLER, A DRIVELINE DISCONNECT AND NO EXTERNAL POWER WERE SEEN. THE PERIODIC LOG FILE CONFIRMED THE REPORTED BACKUP BATTERY FAULTS ON (B)(6) 2025. THE EMERGENCY BACKUP BATTERY DID NOT PASS THE INTERNAL LOAD TEST. THE ALARM APPEARED TO HAVE SELF-RESOLVED. AS A PRECAUTION, IT WAS RECOMMENDED TO RESEAT EBB RIBBON CABLE. THE DRIVELINE DISCONNECT OR NO EXTERNAL POWER ALARM WERE UNABLE TO BE SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521585 ↗
• MalfunctionMay 13, 2025Disconnection; Mechanical Problem; Electrical Power Problem; Complete Loss of Power; Disconnection; Mechanical Problem; Electrical Power Problem; Complete Loss of Power

  IT WAS LATER REPORTED THAT THE PATIENT'S SPOUSE SAID THAT THE PATIENT APPEARED TO NOT BE CONNECTED TO BATTERIES WHEN THEY FOUND THEM DOWN AT HOME. THE ALARMS WERE SAID TO HAVE RESOLVED WHEN THE PATIENT WAS RECONNECTED TO POWER. THE PATIENT WAS SAID TO BE IN PALLIATIVE CARE AT HOME AND WITH A POSSIBLE TRANSITION TO HOSPICE CARE SECONDARY TO RIGHT HEART FAILURE. THE MPU WAS ALSO NOTED TO HAVE A V-LOCK CONNECTOR ON THE AC POWER CORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013050 ↗
• MalfunctionApr 3, 2025Nonstandard Device; Expiration Date Error; Data Problem; Nonstandard Device; Expiration Date Error; Data Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN CLINIC AFTER COMPLAINING ON INTERMITTENT VENTRICULAR ASSIST DEVICE (VAD) ALARMS WITH NOTHING APPEARING ON ALARM HISTORY. WHEN THE DEVICE WAS INTERROGATED, THE ALARM WAS UNABLE TO BE RECREATED BUT NOTICED THAT THE EMERGENCY BACKUP BATTERY (EBB) WAS DEPLETED. THIS WAS REPLACED IN CLINIC, BUT THE SITE WAS CONCERNED THAT THERE WAS NO ALARM OR YELLOW WRENCH TO INDICATE THIS AT 4 MONTHS. LOG FILES WERE SENT FOR REVIEW, AND THE EVENT LOG CAPTURED THE EBB FAULTS THROUGHOUT THE LOG DUE TO IT BEING EXPIRED. THE EBB WAS REPLACED. THE ALARM WAS RESOLVED AFTER BATTERY EXCHANGE, AND THERE WAS NO ADVERSE PATIENT EFFECT DUE TO THE EXPIRED BATTERY. NO PRODUCTS WOULD RETURN, AND THE PATIENT IS ALIVE WITH NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762878 ↗
• MalfunctionNov 1, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR EVALUATION CONCERNING DRIVELINE POWER FAULT ALARM. THE EVENT LOG CAPTURED A DRIVELINE POWER FAULT ALARM ON (B)(6) 2023 AT 12:23:39. AT THE TIME OF THE EVENT, THE PATIENT WAS CONNECTED TO A CONTROLLER WITH LOW FLOW 2.0 SOFTWARE. THE CONTROLLER WAS EXCHANGED TO A STANDARD SYSTEM CONTROLLER AND THE ALARM WAS RESOLVED. THE LOG FILES FROM THE NEWLY CONNECTED CONTROLLER CONTAINED NO DRIVELINE FAULTS INDICATING THAT THERE WERE NO ISSUES WITH THE MODULAR CABLE OR THE DRIVELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049514 ↗
• MalfunctionOct 3, 2023Complete Loss of Power; Complete Loss of Power

  RELATED MANUFACTURER REPORT NUMBER: 2916596-2023-06963. IT WAS REPORTED THAT THE PATIENT'S PUMP TURNED OFF. THE PATIENT RECALLED WAKING UP AND CHANGING THEIR BATTERIES, BUT THE PUMP DID NOT RESTART AND SUSPECTED IT HAD BEEN OFF FOR 30 MINUTES. THE PATIENT WAS BROUGHT TO THE HOSPITAL FOR MEDICAL MANAGEMENT. IT WAS LATER REPORTED THAT NO CAUSE FOR THE PUMP STOP HAD BEEN IDENTIFIED. THE PATIENT'S LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS DECOMMISSIONED ON (B)(6) 2023, AND THE PATIENT REMAINED OFF OF LVAD SUPPORT AS OF (B)(6) 2023. THE PLAN OF CARE WAS MEDICAL MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861981 ↗
• MalfunctionSep 25, 2023Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  RELATED MFR # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814257 ↗
• MalfunctionAug 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DEVICE HAD ZERO FLOW ON LOW FLOW CONTROLLER. LOG FILE ANALYSIS CONTAINED A SUDDEN DROP IN ESTIMATED FLOW STARTING @11:36AM ON (B)(6) 2021 UNTIL THE END OF THIS LOG FILE @1:23PM ON (B)(6) 2021. THE PATIENT WAS REPORTED AS DOING OKAY, FLOWS WERE BACK AND THE PATIENT GOT ADMITTED FOR A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). THE CONTROLLER AND MODULAR CABLE WERE SWAPPED AND THIS APPEARED TO HAVE RESOLVED THE ALARMS. THE CTA WAS PERFORMED ON (B)(6) 2021 DUE TO CONTRAST ALLERGY AND PATIENT NEEDED ADMISSION FOR STEROIDS PREMED. RELATED MFR. REPORT NUMBERS: 2916596-2021-04161 AND 2916596-2021-04216.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259100 ↗
• MalfunctionJul 1, 2021Failure to Power Up; Electrical Power Problem; Failure to Power Up; Electrical Power Problem

  RELATED MANUFACTURER REPORT NUMBERS: 2916596-2021-03377 AND 2916596-2021-03354. IT WAS REPORTED THAT THE PATIENT CALLED WITH ALARM FOR PUMP NOT RUNNING AND WAS BROUGHT INTO THE EMERGENCY DEPARTMENT. THE PATIENT WAS AWOKEN BY AN AUDIBLE ALARM THAT INSTRUCTED THE PATIENT TO CALL HOSPITAL CONTACT. THE PATIENT EXCHANGED THE CONTROLLER AND WHEN SHE WENT BACK TO THE PRIMARY SYSTEM CONTROLLER, THE PUMP DID NOT RESTART FOR A PERIOD OF TIME. THE PATIENT CALLED THE VAD COORDINATOR STATING THE GREEN LIGHT ON THE CONTROLLER WAS NOT LIT UP BUT EVENTUALLY DID COME BACK ON DURING THE PHONE CALL. THE PATIENT WAS BROUGHT INTO THE EMERGENCY DEPARTMENT. NO DRIVELINE DAMAGE WAS REPORTED. MANIPULATION OF THE DRIVELINE AND POWER CABLES DID NOT REPLICATE THE ALARMS. THE PATIENT WAS ASYMPTOMATIC. LOG FILE ANALYSIS CAPTURED BACKUP BATTERY FAULT ALARMS ON (B)(6) 2021 AT 2:14:20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12102669 ↗
• MalfunctionApr 6, 2021Mechanical Problem; Complete Loss of Power; Mechanical Problem; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT HAD A SHORT TO SHIELD ON EITHER WHITE OR BLACK CABLE CREATING POWER SHORTAGE. THE PATIENT WAS GIVEN A NEW CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624365 ↗
• MalfunctionJan 4, 2021Improper or Incorrect Procedure or Method; Complete Loss of Power; Improper or Incorrect Procedure or Method; Complete Loss of Power

  REFERENCE MFR REPORT NUMBER: 2916596-2020-06400. IT WAS REPORTED THAT THE PATIENT WAS SLEEPING ON BATTERIES AND THE BATTERIES EXPIRED. AT THAT POINT, THE EMERGENCY BACKUP BATTERY ENGAGED, BUT IT TOO EVENTUALLY EXPIRED. THE PATIENT'S PUMP WAS OFF FOR AN UNKNOWN AMOUNT OF TIME BEFORE THE PATIENT WOKE UP, WALKED TO THE MOBILE POWER UNIT (MPU), CONNECTED HERSELF BACK TO POWER, AND THE PUMP RESTARTED. THE PATIENT DENIES HEARING ANY ALARMS. FORTUNATELY, THE PATIENT RECOVERED LEFT VENTRICULAR FUNCTION WITH LEFT VENTRICULAR EJECTION FRACTION (LVEF) AT 55% WITH AORTIC VALVE (AV) OPENING, BUT HAS VERY POOR RIGHT VENTRICULAR (RV) FUNCTION. THE PATIENT THINKS THIS HAPPENED ON SATURDAY NIGHT/SUNDAY AM, BUT IT IS DIFFICULT TO TELL BY INTERROGATION BECAUSE THE DATE WAS RESET WHEN THE CONTROLLER AND PUMP LOST POWER. THE PATIENT WAS EDUCATED ON NEVER SLEEPING ON BATTERIES AND TO ALWAYS USE THE MPU. THE VAD COORDINATOR DEMONSTRATED THE ALARM DIFFERENCE BETWEEN BEING CONNECTED TO BATTERY POWER VERSES MPU AS THE MPU AMPLIFIES THE ALARMS. THE PATIENT ALSO UNDERSTANDS TO CHANGE TO BATTERIES IN THE MPU TO ENSURE ALARM FUNCTION AND WILL DO THIS WHEN SHE GETS HOME. THE PATIENT DENIED ANY SYMPTOMS AND HER I

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11109111 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160054. One submission often covers many models, so check the product and lot details in each record.

• Z-2519-2026 · May 13, 2026 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts
• Z-2520-2026 · May 13, 2026 · Open, Classified
  Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Stan
• Z-2518-2026 · May 13, 2026 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left
• Z-0505-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS
• Z-0506-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531
• Z-2290-2025 · Jun 23, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assis
• Z-2291-2025 · Jun 23, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS)
• Z-1570-2025 · Mar 13, 2025 · Open, Classified
  HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
• Z-1921-2024 · May 8, 2024 · Open, Classified
  Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
• Z-1693-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
• Z-1692-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
• Z-1301-2024 · Feb 19, 2024 · Open, Classified
  HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graf
• Z-0842-2024 · Jan 3, 2024 · Open, Classified
  1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate T
• Z-0746-2020 · Dec 2, 2019 · Terminated
  HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, R
• Z-2348-2019 · Mar 30, 2019 · Terminated
  Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System

…and 2 more.