HEARTMATE®, MOBILE POWER UNIT, NA 107754Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,098 adverse event reports that list this exact device (DI 00813024010883), received between Jun 11, 2018 and Sep 30, 2026 — classified as 1 death, 51 injuries, 2,046 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (1,192 reports).

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 25 most recent of 2,098 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Disconnection; Electrical Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951932 ↗
• MalfunctionSep 29, 2026Disconnection; Electrical Power Problem; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938348 ↗
• MalfunctionSep 28, 2026Complete Loss of Power

  Review of the submitted Log Files revealed events consistent with a loss of external power while connected to the Mobile Power Unit (MPU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914684 ↗
• MalfunctionSep 25, 2026Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902906 ↗
• MalfunctionSep 25, 2026Disconnection

  It was reported that the patient had "attach power" Alarms despite being on fully charged Batteries without identifying a specific Power Cable/ Battery. Log Files were sent for review and the Event Log Files recorded a No External Power Event on (b)(6)2026 at 12:57:09 while connected to Mobile Power Unit (MPU) Power. The Backup Battery was used to support the system during the No External Power event. The Motor Function was not affected by this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900428 ↗
• MalfunctionSep 25, 2026Complete Loss of Power

  It was reported that the patient had many No External Power Alarms. The patient stated that they pull on the Mobile Power Unit (MPU) when going to the restroom and wanted to verify how often the event occurred. The Log Files were submitted for review. No External Power Events were recorded on (b)(6) 2026 at 1:01:17 and on (b)(6) 2026 at 3:11:32 that was likely caused by power to the MPU being briefly interrupted. There was another No External Power Event recorded on (b)(6) 2026 at 20:23:13 that appeared to have been accidental as the patient was attempting to switch from the MPU to Battery power. The Emergency Backup Battery (EBB) was used to support the system during the events. The EBB use count was 7.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899838 ↗
• MalfunctionSep 25, 2026Use of Device Problem; Insufficient Device Problem Information

  It was reported that the patient's Mobile Power Unit (MPU) had not been functioning properly and had been replaced on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896261 ↗
• MalfunctionSep 24, 2026Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888941 ↗
• MalfunctionSep 24, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884573 ↗
• MalfunctionSep 24, 2026Complete Loss of Power

  A review of the submitted Log Files captured a No External Power alarm 22:09:00 on (b)(6) 2026 which appeared consistent with a loss of alternating current (AC) power to the Mobile Power Unit (MPU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883517 ↗
• MalfunctionSep 24, 2026Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882592 ↗
• MalfunctionSep 9, 2026Disconnection; Electrical Power Problem; Complete Loss of Power

  It was reported that Log Files were submitted. Upon review, Log Files captured a cluster of Power Cable Disconnect, Low Power Hazard, and No External Power Alarms on (b)(6) 2026. This was caused by power to the Mobile Power Unit (MPU) being briefly interrupted. There was no interruption in Pump support during these events and the Emergency Backup Battery was used. The Mechanical Circulatory Support (MCS) equipment appeared to be operating as intended. On (b)(6) 2026, additional Log Files were submitted. Upon review, the Event Log captured Power Cable Disconnect, Low Power Hazard, and No External Power Alarms while connected to the Mobile Power Unit (MPU) on (b)(6) 2026 at 07:42. The alarms appeared to have resolved when the MPU regained power.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691111 ↗
• MalfunctionSep 8, 2026Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676627 ↗
• MalfunctionSep 3, 2026Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50597879 ↗
• MalfunctionSep 2, 2026Disconnection; Electrical Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571689 ↗
• MalfunctionAug 31, 2026Disconnection; Electrical Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50532343 ↗
• MalfunctionAug 28, 2026Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50500629 ↗
• MalfunctionJul 27, 2026Material Deformation; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50001588 ↗
• MalfunctionFeb 20, 2026Electrical Power Problem; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HOME EXPLOSION. THEIR EQUIPMENT DID NOT APPEAR TO BE DAMAGED. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED SOME ODD LOW POWER HAZARD ALARMS ON (B)(6) 2025. REVIEW OF THE SUBMITTED LOG FILES CAPTURED LOW POWER HAZARD ALARMS ON (B)(6) 2025 THAT APPEARED TO BE DUE TO A NO EXTERNAL POWER EVENT WHILE THE PATIENT WAS OPERATING ON THE MOBILE POWER UNIT (MPU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405586 ↗
• MalfunctionFeb 17, 2026Complete Loss of Power

  IT WAS REPORTED THAT LOG FILE REVIEW WAS REQUESTED WHICH REVEALED POWER CABLE DISCONNECT AND NO EXTERNAL POWER EVENTS WHILE ON MOBILE POWER UNIT (MPU) POWER ON (B)(6) 2026 AT 02:17 AND ON (B)(6) 2026 AT 23:09. THIS WAS CAUSED BY POWER TO THE MPU BEING BRIEFLY INTERRUPTED. THERE WAS NO PUMP INTERRUPTION DURING THESE EVENTS AS THE SYSTEM CONTROLLER'S EMERGENCY BACKUP BATTERY (EBB) FUNCTIONED AS INTENDED. THE ALARMS RESOLVED WHEN THE MPU REGAINED POWER. NO OTHER UNUSUAL EVENTS WERE NOTED IN THE LOG FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368507 ↗
• MalfunctionFeb 16, 2026Complete Loss of Power

  IT WAS REPORTED THAT LOW POWER HAZARD AND NO EXTERNAL POWER ALARMS WERE NOTED IN THE LOG FILES WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU) ON (B)(6) 2025. THE MPU DID HAVE A V-LOVK CONNECTOR ON THE AC POWER CORD, AND THE PATIENT DID NOT REPORT ANY ENVIRONMENTAL CIRCUMSTANCES AT THE TIME OF THE EVENT. THE MPU WAS REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345972 ↗
• MalfunctionFeb 3, 2026Electrical Power Problem; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT'S LOG FILES WERE SENT FOR REVIEW. FOLLOWING REVIEW, IT APPEARED THAT THE EVENT LOG CAPTURED LOW VOLTAGE HAZARD EVENTS WHILE USING THE MOBILE POWER UNIT (MPU). IT APPEARED THAT THE MPU LOST POWER BRIEFLY (3 SECONDS), WHICH ENABLED THE EMERGENCY BACKUP BATTERY (EBB) IN THE SYSTEM CONTROLLER UNTIL POWER WAS RESTORED TO THE MPU. THERE WERE NO OTHER UNUSUAL EVENTS NOTED IN THE LOG FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24253588 ↗
• MalfunctionFeb 2, 2026Electrical Power Problem; No Apparent Adverse Event

  IT WAS REPORTED THE PATIENT HAD SEVERAL LOW VOLTAGE ADVISORY ALARMS. LOG FILE REVIEW WAS REQUESTED WHICH REVEALED LOW POWER ADVISORY ALARMS WHILE ON BATTERY POWER ON 20JAN2026 FROM 15:26 TO 23:11. THIS INDICATES THE WHITE POWER CABLE MAY HAVE A POOR CONNECTION WITH THE BATTERY CLIPS. THE ALARMS RESOLVED WHEN A NEW FULLY CHARGED BATTERY WAS CONNECTED. ADDITIONALLY POWER CABLE DISCONNECTS AND NO EXTERNAL POWER ALARMS WERE NOTED ON 21JAN2026 AT 07:11. THIS WAS CAUSED BY POWER TO THE MOBILE POWER UNIT (MPU) BEING BRIEFLY INTERRUPTED. THE EMERGENCY BACKUP BATTERY (EBB) SUPPORTED THE PUMP DURING THIS EVENT. THE ALARM'S RESOLVE UPON THE MOBILE POWER UNIT (MPU) REGAINING POWER. NO OTHER UNUSUAL ALARMS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241659 ↗
• MalfunctionJan 29, 2026Complete Loss of Power

  IT WAS REPORTED THAT A LOG FILE REVIEW SHOWED NO EXTERNAL POWER, LOW POWER HAZARD, AND POWER CABLE DISCONNECT EVENTS ON 04JAN2026. THESE ALARM TYPES OCCURRED WHILE THE PATIENT WAS CONNECTED TO THE MOBILE POWER UNIT (MPU). THIS WAS CAUSED BY POWER TO THE MPU BEING BRIEFLY INTERRUPTED. THERE WAS NO PUMP INTERRUPTION DURING THESE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24217880 ↗
• MalfunctionJan 29, 2026Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT HAD LOW VOLTAGE ALARMS WHILE CONNECTED TO THE CABLE. LOG FILES WERE SUBMITTED FOR REVIEW. FOLLOWING REVIEW, IT APPEARED THAT THE LOG FILE CAPTURED 10 CLUSTERS OF NO EXTERNAL POWER, LOW POWER HAZARD, AND POWER CABLE DISCONNECT EVENTS ON 14JAN2026 AND 15JAN2026. THE LOG FILE CAPTURED A NO EXTERNAL POWER ALARM AND MULTIPLE OTHER ASSOCIATED ALARM TYPES WHILE THE PATIENT WAS CONNECTED TO THE MOBILE POWER UNIT (MPU). THIS APPEARED TO HAVE BEEN CAUSED BY POWER TO THE MPU BEING BRIEFLY INTERRUPTED. THERE WAS NO PUMP INTERRUPTION DURING THE EVENTS AS THE SYSTEM CONTROLLER'S EMERGENCY BACKUP BATTERY (EBB) FUNCTIONED AS INTENDED. IT DID NOT APPEAR THAT THE PATIENT HAD BEEN SLEEPING ON BATTERY POWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214016 ↗