HeartMate™ 107760Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05415067038258), received between Jan 23, 2023 and Aug 5, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (3 reports).

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

31 other recalls cover devices cleared under the same FDA submission (P060040, 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 23, 2025Open, Classified

   Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.

   Z-2290-2025 · Root cause: Vendor change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THERE WERE NO LOG FILES AVAILABLE. THE MPU HAD A YELLOW CLIP, WHICH THEY THOUGHT MAY HAVE BEEN THE V-LOCK CONNECTOR ON THE AC POWER CORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713158 ↗
• MalfunctionJan 12, 2024Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT NO DAMAGE WAS NOTED TO THE SHIPPING BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18505076 ↗
• MalfunctionApr 24, 2023Complete Loss of Power; Complete Loss of Power

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE AC POWER CORD DID NOT COME LOOSE AT THE WALL OUTLET OR AT THE BACK OF THE UNIT. NO ENVIRONMENTAL CIRCUMSTANCES WERE NOTED THAT MAY HAVE AFFECTED AC POWER AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797254 ↗
• MalfunctionApr 10, 2023Disconnection; Electrical Power Problem; Disconnection; Electrical Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707235 ↗
• MalfunctionMar 14, 2023Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THROUGH LOG FILES THAT A NO EXTERNAL POWER EVENT OCCURRED ON 28DEC2022 WHILE THE PATIENT WAS OPERATING ON THE MOBILE POWER UNIT (MPU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536765 ↗
• MalfunctionJan 23, 2023Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THROUGH LOG FILES THAT MULTIPLE NO EXTERNAL POWER ALARMS WERE CAPTURED WHILE ON THE MOBILE POWER UNIT (MPU). THEY WERE CAUSED BY POWER TO THE MPU BEING BRIEFLY INTERRUPTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16227257 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060040, P160054. One submission often covers many models, so check the product and lot details in each record.

• 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-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-0508-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate II Controller (standalone) Model/Catalog Number: 106017, HeartMate II Pocket Controller, US; 106762, HeartMate II Pocket Controller, U
• Z-0507-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate II LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II LVAS
• 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-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-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-1300-2024 · Feb 19, 2024 · Open, Classified
  HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate
• 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

…and 16 more.