Thoratec® HeartMate 3™ 10005872Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00813024013075), received between Dec 13, 2018 and Jun 2, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (3 reports).

18 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Mechanical Problem; Material Twisted/Bent; Mechanical Problem; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE UNPACKING THE CORING TOOL, THE PERFUSIONIST RECOGNIZED A BEND IN THE CENTER PIN AND THE HELIX OF THE CORING TOOL. ANOTHER CORING TOOL WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126227 ↗
• MalfunctionMar 5, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON NOTED THAT CORING THE APEX WITH THE CORING TOOL WAS NOT POSSIBLE SINCE THE CORING TOOL WAS NOT SHARP ENOUGH. THE SURGEON USED THE CORING KNIFE OF THE IMPLANT KIT. CORING WITH THE CORING KNIFE WENT WITHOUT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838070 ↗
• MalfunctionMay 26, 2023Dull, Blunt; Dull, Blunt

  THE RETRIEVAL OF AN ADDITIONAL CORING KNIFE RESULTED IN A DELAY OF APPROXIMATELY 3-5 MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011765 ↗
• MalfunctionMay 3, 2023Dull, Blunt; Dull, Blunt

  THERE WERE NO PATIENT CONSEQUENCES AS A RESULT OF THE EVENT, AND THERE WAS A 5-MINUTE DELAY IN SURGERY TO RETRIEVE A BACKUP CORING KNIFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862423 ↗
• MalfunctionOct 6, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE SURGEON WAS UTILIZING THE CORING TOOL AND IT REQUIRED MORE THAN 3 ROTATIONS ONCE THE HELIX WAS IN THE VENTRICLE. POST-OPERATIVE THE PATIENT WAS DOING WELL. THE MALFUNCTION DID NOT RESULT IN PROLONGED SURGERY TIME AND THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15552113 ↗
• MalfunctionAug 9, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A CORING TOOL PIN MALFUNCTION. THE PIN ON THE CORING TOOL WAS CROOKED WHEN PULLED OUT OF THE LEFT VENTRICLE. IT WAS PROTRUDING THROUGH THE HELIX INSTEAD OF CENTRAL TO THE HELIX AFTER DEPLOYMENT OF THE BLADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196247 ↗
• InjuryNov 12, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A HEARTMATE 3 IMPLANT, A CORING TOOL USED HAD NO TISSUE CORE COME OUT WITH IT DURING THE CORING PROCESS. AFTER EXAMINATION OF THE TOOL, THE METAL SPIKE APPEARED TO BE OUTSIDE OF THE SPIRAL WHICH IS ABNORMAL. A VISUAL INSPECTION WAS PERFORMED, AND NO CORE WAS FOUND IN THE PATIENT'S HEART OR CHEST. AN ECHOCARDIOGRAM, ENDOSCOPIC PROCEDURE AND COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY WERE ALSO PERFORMED TO CHECK FOR THE CORE; NO CORE WAS FOUND. THE PATIENT'S VENTRICLE WAS NOTED TO BE SLIGHTLY CALCIFIED. THE PATIENT WAS PROGRESSING WELL AFTER THEIR IMPLANT. THE SITE SENT THE TOOL BACK FOR ANALYSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807609 ↗
• InjuryMar 12, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION, THE SURGEON USED THE CORING TOOL FOR THE VENTRICULOTOMY. THE LEFT VENTRICLE (LV) TISSUE THICKNESS WAS 10 MM. THE SURGEON USED THE CORING TOOL CORRECTLY BUT THE TOOL DID NOT MOVE IN THE LV TISSUE PREPARATION. THE TOOL WAS REMOVED FROM THE TISSUE COUNTERCLOCKWISE. THE SECTION WAS CORRECT AND THE TISSUE PREPARATION WAS COMPLETE AND COULD BE REMOVED WITH TWEEZERS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8415251 ↗
• InjuryMar 12, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT FOR IMPLANT OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2019. THE CORING TOOL WAS USED ACCORDING TO THE MANUFACTURER¿S INSTRUCTIONS. AFTER CORING, THE LVAD WAS INSERTED AND THE PATIENT WAS WEANED FROM ECMO SUPPORT. EVERYTHING SEEMED OK, THEN SUDDENLY THE CALCULATED LVAD FLOW DROPPED TO LESS THAN 1 L/MIN. ECHOCARDIOGRAPHY SHOWED NO FLOW IN THE INFLOW CANNULA. A RAMP TEST SHOWED THAT THE PUMP WAS NOT ABLE TO RELIEVE THE LEFT VENTRICLE. THE PATIENT WAS PLACED BACK ON ECMO SUPPORT. THE LVAD WAS DISCONNECTED FROM THE APICAL RING AND IT WAS OBSERVED THAT PART OF THE CORE WAS STILL ATTACHED TO THE VENTRICOLOTOMY. AFTER REMOVING THE LEFTOVER MATERIAL, THE SURGEON CHECKED FOR MATERIAL INSIDE THE CORING DEVICE AND FOUND NOTHING. THE EXPLANTED LVAD WAS PLACED IN A WATER BASIN AND THE DEVICE WAS STARTED, BUT IT WAS NOT ABLE TO GENERATE GOOD FLOWS UNDER INCREASING SPEED. THE SURGEON SUSPECTED THAT MATERIAL WAS INGESTED INTO THE PUMP AND DECIDED TO IMPLANT THE BACKUP DEVICE. THE PATIENT`S CONDITION WAS STABLE DURING THE PROCEDURE. THE PATIENT WAS WEANED FROM ECMO SUPPORT WITH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8415242 ↗
• MalfunctionDec 13, 2018Contamination; Contamination

  DURING THE IMPLANT PROCEDURE, IT WAS REPORTED THAT UPON INSPECTION AFTER CORING THE LEFT VENTRICLE WITH THE NEW HM3 CORING TOOL, SURGEON IDENTIFIED A PIECE OF BLACK PLASTIC IN THE HEART CHAMBER. PLASTIC COMPONENT WAS REMOVED FROM THE VENTRICLE AND APPEARED TO COME FROM THE BLACK HANDLE OF CORING KNIFE. A SMALL PIECE AND REMAINDER OF BLACK CAP WILL BE RETURNED FOR INVESTIGATION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8161068 ↗

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-2583-2024 · Jun 25, 2024 · Open, Classified
  HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Ki
• 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-1692-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
• Z-1693-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, 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

…and 3 more.