Thoratec® HeartMate 3™ 106522USRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05415067030801), received between Dec 26, 2019 and Feb 14, 2022 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE TUNNELING ADAPTOR WAS DROPPED WHILE TRYING TO CONNECT TO THE PUMP CABLE DURING PUMP PREPARATION AND THE APICAL CUFF WAS UNABLE TO CONNECT TO THE PUMP. THE BACKUP ADAPTOR AND CUFF WERE USED INSTEAD OF THE ORIGINAL KIT. THE PATIENT WAS RECOVERING IN THE INTENSIVE CARE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524152 ↗
• InjuryMar 11, 2021Fluid/Blood Leak; Device Difficult to Setup or Prepare; Fluid/Blood Leak; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THERE WAS BLEEDING AFTER THE PUMP WAS LOCKED INTO THE APICAL CUFF. THE SOURCE OF BLEEDING WAS BETWEEN THE APICAL CUFF AND THE PUMP. THE BLEEDING RESOLVED AFTER DISENGAGING THE PUMP FROM APICAL CUFF 3 TIMES. RELATED MANUFACTURER REPORT NUMBER 2916596-2021-01348.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11465542 ↗
• InjuryDec 17, 2020Fluid/Blood Leak; Device Difficult to Setup or Prepare; Fluid/Blood Leak; Device Difficult to Setup or Prepare

  RELATED MFR NUMBER: 2916596-2020-05966. IT WAS REPORTED THAT DURING THE (B)(6) 2020 THORACOTOMY IMPLANT, BLEEDING WAS OBSERVED FROM THE INTERFACE BETWEEN THE PUMP INFLOW CANNULA AND THE APICAL SEWING RING. PRIOR TO THE BLEEDING, THE SURGEON SUTURED THE APICAL SEWING RING TO THE LEFT VENTRICULAR (LV) APEX, THEN CORED UTILIZING THE CORING KNIFE; ADDITIONAL TISSUE WAS REMOVED FROM THE APEX UTILIZING SURGICAL TOOLS. THE SURGEON USED 4 PLEDGED SUTURES AND RAN THE SUTURES TO ADHERE THE SEWING RING TO THE LV APEX. SURGICAL ADHESIVE WAS PLACED AROUND THE PERIMETER OF THE SEWING RING. THE PUMP WAS PLACED INTO THE LEFT VENTRICLE AND ENGAGED; AS EVIDENCED BY THE YELLOW LINES DISAPPEARING ON THE PURPLE CUFF LOCK. WHILE PERFORMING THE OUTFLOW GRAFT ANASTOMOSIS, BLEEDING WAS OBSERVED FROM THE LV APEX BETWEEN THE PUMP AND THE SEWING RING. THE SURGEON ADDED MULTIPLE PLEDGED SUTURES; BLEEDING CONTINUED. THE PURPLE CUFF LOCK WAS DISENGAGED TO TRY TO RE-SEAT THE PUMP TWO TIMES ON THE APICAL SEWING RING; BLEEDING CONTINUED. THE PATIENT WAS PUT BACK ON CORONARY BYPASS, AND THE HEARTMATE 3 PUMP WAS REMOVED FROM THE LV APEX TO INSPECT THE PURPLE CUFF LOCK PRONGS THAT ENGAGE WITH THE SEWING RING. THE PURP

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11032973 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE ORIGINAL APICAL CUFF WAS IMPLANTED, THE SUTURE LINE WAS BLEEDING AND COULD NOT BE CONTROLLED. THE SURGEON MADE THE DECISION TO REMOVE THE CUFF AND START AGAIN WITH A FRESH APICAL CUFF. THE ADDITIONAL CUFF WAS OPENED AND THE NEW SERIAL NUMBER WAS PLACED ON THE PATIENT¿S DOCUMENTATION IN PLACE OF THE ORIGINAL CUFF STICKERS.

  Patient problems: Blood Loss

  MAUDE report 10528109 ↗
• InjuryAug 6, 2020Fluid/Blood Leak; Device Difficult to Setup or Prepare; Fluid/Blood Leak; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERSISTENT BLEEDING BETWEEN THE METAL AT THE CUFF POST-OP. THE HEARTMATE 3 WAS INITIALLY ENGAGED WITH THE APICAL CUFF THEN THE CUFF WAS REMOVED WITH UNLOCKING TOOL AFTER DIFFICULTY GETTING THE TOOL TO DISENGAGE THE LOCKING MECHANISM. THE IMPLANT APPROACH WAS VIA INTERCOSTAL, BILATERAL THORACOTOMY. THE PUMP ENGAGED AGAIN BUT THE PATIENT CONTINUED TO BLEED AROUND THE PUMP. THIS IS THOUGHT TO BE DUE TO POOR ENGAGEMENT BETWEEN THE PUMP/CUFF. ADDITIONAL INFORMATION: THE PUMP WAS NOT REPLACED AND THE BLEEDING RESOLVED AFTER UMBILICAL TAPE WAS USED AROUND INFLOW CANNULA TO SECURE THE PUMP AND APICAL CUFF ENGAGEMENT AND RESOLVE BLEEDING. THE PATIENT IS STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10372525 ↗
• InjuryJun 10, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  RELATED MANUFACTURER'S REPORT NUMBER: 2916596-2020-02869. IT WAS REPORTED THAT DURING THE IMPLANT, THERE WAS BLEEDING NOTED TO BE COMING FROM BETWEEN THE APICAL CUFF AND PUMP ATTACHMENT. IT WAS ATTEMPTED TO SLIGHTLY TURN THE PUMP. IT ENDED UP UNLOCKING THE CUFF LOCK, PUSHING DOWN ON THE PUMP, GIVING A SLIGHT ROTATION, AND RE-ENGAGING THE CUFF LOCK. THE BLEEDING STOPPED.

  Patient problems: Blood Loss

  MAUDE report 10140772 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANT THE PATIENT HAD BLEEDING BELOW THE MINI APICAL CUFF THAT REQUIRED THE PLACEMENT OF 2 UMBILICAL TAPES DISTAL. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: Blood Loss

  MAUDE report 9519636 ↗

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-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-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-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-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-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-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.