HeartMate™ 2865Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067039644), received between Dec 15, 2025 and Dec 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Disconnection; Mechanical Problem; Device Difficult to Setup or Prepare; Electrical Power Problem; Disconnection; Mechanical Problem; Device Difficult to Setup or Prepare; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT SPILT LISTERINE ON THEIR VENTRICULAR ASSIST DEVICE (VAD) EQUIPMENT. ONE OF THE AFFECTED FAULT BATTERY CLIPS WON¿T CONNECT AND WAS TAKEN OUT OF SERVICE. THE OTHER BATTERIES AND CLIPS WERE WORKING. A COUPLE HOURS LATER WHEN TRANSFERRING FROM WALL POWER TO BATTERY POWER, THE BLACK POWER CORD ALARMED FOR POOR CONNECTION WITH FULLY CHARGED BATTERIES AND NEW CLIPS. INTERROGATION ALSO REVEALED DOUBLE POWER CABLE DISCONNECT, WHICH THE PATIENT ADMITTED TO ACCIDENTALLY DOUBLE POWER CABLE DISCONNECTING. LOG FILES WERE SENT FOR URGENT REVIEW TO DETERMINE IF A SYSTEM CONTROLLER EXCHANGE WAS NECESSARY. FOLLOWING REVIEW, IT APPEARED THAT THE EVENT LOG CAPTURED A SHORT PERIOD OF LOW VOLTAGE ADVISORY EVENTS WHILE USING BATTERY POWER ON (B)(6) 2025 AT 0916 THROUGH 1020. IT APPEARED TO HAVE BEEN FROM NORMAL BATTERY DEPLETION. THERE WERE ALSO LOW VOLTAGE/NO EXTERNAL POWER EVENTS ON (B)(6) 2025 AT 1900 WHILE USING THE MOBILE POWER UNIT (MPU). IT APPEARED THAT THE MPU LOST TOTAL POWER, WHICH ENABLED THE EMERGENCY BACKUP BATTERY (EBB) IN THE CONTROLLER UNTIL POWER WAS RESTORED TO THE MPU. THE EVENT LASTED ABOUT 6 SECONDS. ON (B)(6) 2025 AT 1655, THE LOG CAPTURED LOW VOLTA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804187 ↗

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-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-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-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-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-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-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

…and 3 more.