HeartMate 3™ 106525USRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05415067039385), received between Oct 16, 2025 and Sep 28, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923275 ↗
• MalfunctionSep 25, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902768 ↗
• MalfunctionSep 16, 2026Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792603 ↗
• MalfunctionAug 18, 2026Electrical /Electronic Property Problem; Mechanical Problem

  It was later communicated that liquid contamination in the operating room (OR) was suspected as the cause.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308043 ↗
• MalfunctionAug 4, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133541 ↗
• MalfunctionJul 26, 2026No Apparent Adverse Event

  It was reported that the patient presented to the Emergency Department (ED) with Driveline Power Fault Alarms that begun on Saturday afternoon. The patient had the Modular Cable replaced twice prior, 3 months ago, and 3 months before that. The replacement was also triggered by Driveline Power Faults at the time. There was no visible damage to the Driveline. Log Files confirmed Driveline Power B Fault Alarms on (b)(6) 2025. The alarm had not interfered with Pump operation. The site replaced the Modular Cable and System Controller on (b)(6) 2025, and no alarms were noted to return. Per Technical Services (TS), there was corrosion noted on the Pump Inline Connector and would be onsite for a cleaning. Additional information provided on (b)(6) 2025 noted that on (b)(6) 2025 the Driveline Power Fault Alarms returned. The corrosion was noted to likely be due to water damage, and would be cleaned on (b)(6) 2025. Details provided on (b)(6) 2025 confirmed that the Driveline Power Fault Alarms appeared to clear post Modular Connector cleaning. The noted corrosion was observed upon disconnecting the surface cleaning. The patient was symptomatic during the cleaning, so the team provided inotrop

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000035 ↗
• MalfunctionJan 30, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT HAD RECURRENT "DRIVELINE POWER FAULT" ALARM STARTING ON THE MORNING ON (B)(6) 2026. LAST TIME THIS OCCURRED WAS ON (B)(6) 2025 (MFR#: 2916596-2025-08235) WHERE EQUIPMENT AND MODULAR CABLE CONNECTION WAS INSPECTED AND NO OBVIOUS DAMAGE OR DEBRIS WAS FOUND. ALARM WAS CLEARED AND DID NOT RECUR SO MODULAR CABLE WAS LEFT IN PLACE. THE SITE NOW REPLACED THE MODULAR CABLE CONNECTION AND INSPECTED PUMP SIDE WHERE DUST AND DEBRIS WERE OBSERVED. THE ALARM HAD NOT RETURNED AFTER MODULAR CABLE CHANGE. TECHNICAL SERVICES STATED THAT THE LOG FILES FROM (B)(6) CONFIRMED THE ONSET OF DRIVELINE POWER FAULTS ON (B)(6) 2026. THESE FAULTS WERE ASSOCIATED WITH A POWER A FAULT. THE LOG FILES FROM (B)(6) CONTAINED ALARMS ASSOCIATED WITH THE SYSTEM CONTROLLER SWAP. THE PUMP APPEARED TO RESUME THE PROGRAM SET SPEED IN THE LIMITED DATA RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226591 ↗
• MalfunctionJan 5, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S CONTROLLER WAS RECENTLY EXCHANGED ON (B)(6) 2025 (PEC-ADD CS-221210). THE PATIENT WAS READY TO BE DISCHARGED FROM HOSPITAL AND WAS EXPERIENCING CONNECT TO POWER ISSUES AGAIN. IT APPEARED THAT THE PATIENT HAD SPILLED SOMETHING ON HER BRAND-NEW CONTROLLER. THE MODULAR CABLE CONNECTION ALSO APPEARED TO HAVE RESIDUE. THE BATTERIES AND CLIPS WERE SWAPPED AND CLEANED. LOG FILE ANALYSIS WAS REQUESTED TO ASSESS CURRENT CONTROLLER STATUS. THE EVENT LOG FILE CONTAINED ODD POWER CABLE DISCONNECT ALARMS WHEN THE PATIENT WAS UTILIZING BATTERY POWER. THESE ALARMS APPEARED TO BE A RESULT OF RSOC (BATTERY DATA) INVALID FLAGS. THESE TYPES OF ALARMS WERE TYPICALLY CAUSED BY A POOR CONNECTION BETWEEN THE BATTERIES AND CLIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967004 ↗
• MalfunctionDec 2, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED A CONTROLLER EXCHANGE DUE TO THE CONTROLLER CONNECTIONS BEING CRACKED WITH WATER DAMAGE. THE PATIENT HAD LOW FLOW SOFTWARE INSTALLED ON NEW AND BACKUP SYSTEM CONTROLLERS PER PROVIDER REQUEST. THE PATIENT HAD LOW FLOW SOFTWARE PREVIOUSLY INSTALLED AT TIME IMPLANT. EXPECTED ALARMS OCCURRED DURING EXCHANGE. NO ALARMS WERE ACTIVE PRIOR TO OR AFTER EXCHANGE. THE COORDINATOR THEN EXCHANGED THE PATIENT'S MODULAR CABLE AND SYSTEM CONTROLLER TO THE NEW LOW FLOW CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701126 ↗
• MalfunctionDec 2, 2025Electrical /Electronic Property Problem; Device Difficult to Setup or Prepare; Electrical /Electronic Property Problem; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR EVALUATION FOLLOWING A DRIVELINE POWER FAULT ALARM THAT OCCURRED DURING IMPLANT. THE MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED IN THE OPERATING ROOM (OR), AND THE ORIGINAL MODULAR CABLE AND CONTROLLER WOULD BE RETURNED FOR FURTHER EVALUATION. THE LOG FILES CAPTURED VARIOUS ALARMS ASSOCIATED WITH THE NEW IMPLANT AS WELL AS THE REPORTED DRIVELINE POWER FAULTS. THE DRIVELINE FAULTS WERE ASSOCIATED WITH A CONTROLLER OPEN FUSE B FAULT. CONTROLLER FUSES WILL OPEN DURING OVER CURRENT PROTECTION EVENTS. DURING PUMP PREPARATION, THE CUSTOMER INITIATED SEVERAL ATTEMPTS TO CONNECT THE MODULAR CABLE AND PUMP CABLE BEFORE ULTIMATELY SECURING THE CONNECTION. THE MODULAR CABLE AND CONTROLLER EXCHANGE RESOLVED THE ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698448 ↗
• MalfunctionOct 22, 2025Corroded; Electrical /Electronic Property Problem; Communication or Transmission Problem; Corroded; Electrical /Electronic Property Problem; Communication or Transmission Problem

  THE ORIGINAL MODULAR CABLE CONNECTIONS WERE CORRODED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364006 ↗
• MalfunctionOct 16, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THERE WAS ONLY DIFFICULTY ON FIRST ATTEMPT OUT OF BOX AND HAT THE PATIENT DID NOT SUFFER FROM ANY ADVERSE EVENTS DUE TO THIS. IT WAS CONFIRMED CONNECTION WAS SUCCESSFULLY MADE AFTER ATTEMPTS. THE PATIENT WAS SAID TO HAVE UNDERGONE STANDARD POST OPERATIVE CARE AFTER THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318203 ↗
• MalfunctionOct 16, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT MODULAR CABLE WAS BROKEN. THE MODULAR CABLE WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312640 ↗

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-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-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-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; 106531LF
• 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.