HeartMate®, Mobile Power Unit 108285Recalls & reported problems
Thoratec Corporation · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813024012696), received between Aug 9, 2021 and Jul 14, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Electrical Power Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Electrical Power Problem1
- Failure to Power Up1
- Material Twisted/Bent1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT MOBILE POWER UNIT (MPU) WAS NOT WORKING, TURNED OFF. THE MPU WAS EXCHANGED. THE LOG FILES DID NOT CAPTURE ANY TYPE OF VOLTAGE EVENTS AND ALSO NOTED THAT THE PATIENT WAS ONLY USING BATTERY POWER IN THIS DATA CAPTURE AND NOT THE MPU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22500721 ↗MalfunctionSep 26, 2023Electrical Power Problem; Electrical Power Problem
IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR REVIEW. THE LOG FILES DISPLAYED ONE TRANSIENT LOW VOLTAGE ALARM ON (B)(6) 2023 AT 3:31 PM WHILE TETHERED TO THE MOBILE POWER UNIT (MPU). THIS ALARM SEEMED TO BE CAUSED BY THE POWER TO THE MPU BEING BRIEFLY INTERRUPTED. THIS MIGHT HAVE BEEN DUE TO THE POWER CORD COMING LOOSE FROM THE WALL OUTLET, THE HOUSE LOSING POWER, OR POSSIBLE USER ERROR. THERE WERE NO OTHER UNUSUAL EVENTS SEEN WITHIN THE LOG FILE. THE MECHANICAL CIRCULATORY SYSTEM (MCS) EQUIPMENT OPERATED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17818831 ↗MalfunctionAug 9, 2021Material Twisted/Bent; No Apparent Adverse Event; Material Twisted/Bent; No Apparent Adverse Event
IT WAS REPORTED THAT THE CONNECTOR PINS OF THE PATIENT CABLE WERE BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12293364 ↗
Other Ventricular (Assisst) Bypass devices
- Thoratec® HeartMate 3™ 106524USThoratec Corporation · Ventricular (Assisst) Bypass7 recalls5,096 deaths16,478 reports
- THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) 106015Thoratec Corporation · Ventricular (Assisst) Bypass2 recalls2,141 deaths8,000 reports
- Thoratec® HeartMate 3™ 106531USThoratec Corporation · Ventricular (Assisst) Bypass1 recall11 deaths4,646 reports
- HVAD Pump Implant Kit 1103Heartware Inc. · Ventricular (Assist) Bypass6 recalls424 deaths2,952 reports
- HVAD® Pump Implant Kit (Enhanced) 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls573 deaths2,807 reports
- HVAD® Pump Implant Kit 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls666 deaths2,737 reports
- HVAD® Controller 1420Heartware Inc. · Ventricular (Assisst) Bypass5 recalls14 deaths2,161 reports
- HEARTMATE®, MOBILE POWER UNIT, NA 107754Thoratec Corporation · Ventricular (Assisst) Bypass1 death2,098 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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