HEARTMATE® POWER MODULE (NA) 1340Recalls & reported problems

Summary

The FDA's MAUDE database contains 402 adverse event reports that list this exact device (DI 00813024010654), received between Jul 31, 2018 and Sep 30, 2026 — classified as 1 death, 3 injuries, 398 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (201 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 402 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  It was reported that the Battery and Battery Connection of the Patient Power Module (PPM) was broken. It was planned to send replacement Streamline Cables to the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947029 ↗
• MalfunctionSep 28, 2026Use of Device Problem

  It was reported that the Power Module, PPM-21599, had a Yellow Wrench. The alarm was unable to be cleared. The Battery was reseated and changed to a new Backup Battery with no resolution. The Power Module was planned to be returned for repair.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914280 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem; Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903676 ↗
• MalfunctionSep 24, 2026Mechanical Problem

  It was reported that there was water damage to the Power Module. It was also noted that the Power Module was due for a Battery replacement as well.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885046 ↗
• MalfunctionSep 24, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883584 ↗
• MalfunctionFeb 27, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE POWER MODULE GREEN POWER LED WAS BURNED OUT. UNIT WAS SCHEDULED TO RETURN FOR REPAIR. THERE WAS NO IMPACT TO PATIENT. HOSPITAL-OWNED UNIT. THE ESR AND PICTURES WERE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470889 ↗
• MalfunctionJan 15, 2026Mechanical Problem

  IT WAS REPORTED THAT THE POWER MODULE HAD A DAMAGED CASING AND WOULD BE RETURNED FOR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24083374 ↗
• MalfunctionDec 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THERE WAS DAMAGE TO THE STREAMLINE CABLE ON THE POWER MODULE. A REPLACEMENT FOR THE CABLE WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23915424 ↗
• MalfunctionDec 29, 2025Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT REVIEW OF THE LOG FILES REVEALED A LOSS OF POWER TO THE POWER MODULE ON (B)(6) 2025 WAS IDENTIFIED. THE POWER MODULE BACKUP BATTERY SUPPORTED THE SYSTEM AS INTENDED DURING THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23910540 ↗
• MalfunctionDec 17, 2025Improper or Incorrect Procedure or Method; Complete Loss of Power; Improper or Incorrect Procedure or Method; Complete Loss of Power

  IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR REVIEW, AND IT WAS NOTED BY THE SITE THAT THERE WOULD BE A NO EXTERNAL POWER EVENT CAUSED BY THE PATIENT PARTIALLY DISCONNECTING THE POWER MODULE WHEN PULLING ON THE CABLE WHILE ENTERING THE RESTROOM. THE LOG FILES CAPTURED A NO EXTERNAL POWER ALARM AND MULTIPLE ASSOCIATED ALARMS ON (B)(6) 2025 DUE TO POWER TO THE DEVICE BEING BRIEFLY INTERRUPTED AS REPORTED. THE PATIENT THEN SWITCHED TO BATTERY POWER AND, WHILE DOING SO, CAUSED A FEW LOW POWER ADVISORY EVENTS. THE REMAINDER OF THE LOG FILE WAS UNREMARKABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831551 ↗
• MalfunctionDec 16, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE POWER MODULE JUST CLICKED WHEN PLUGGED IN AND DID NOT TURN ON OR LIGHT UP AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821597 ↗
• MalfunctionDec 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT WAS STABLE AND ADMITTED TO THE EMERGENCY DEPARTMENT. THERE WAS A RED BATTERY ILLUMINATED ON THE POWER MODULE. TROUBLESHOOTING WAS PERFORMED. MULTIPLE RED OUTLETS WERE USED AND SELF-TESTS WERE DONE ON THE MODULE. THE RED BATTERY DID NOT CLEAR. THE NURSE TOOK THE POWER MODULE OUT OF SERVICE AND DISCONNECTED THE BATTERY TO SILENCE THE ALARM. THE PATIENT REMAINED UNAFFECTED AND WAS ON A FULLY CHARGED SET OF BATTERIES AND HAD BACKUP BATTERIES CHARGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820836 ↗
• MalfunctionDec 15, 2025Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT POWER MODULE RED BATTERY WAS ACTIVE AND DID NOT RESOLVE. THERE PROBABLY WAS SOME PHYSICAL DAMAGE TO THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812538 ↗
• MalfunctionDec 12, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE POWER MODULE WAS ALARMING SHOWING A YELLOW WRENCH. THE BATTERY SYMBOL ON THE POWER MODULE WAS STILL GREEN. THEY REPLACED THE POWER MODULE CONNECTED TO THE PATIENT AND EVERYTHING APPEARED TO BE WORKING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794567 ↗
• MalfunctionDec 11, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE GREEN BATTERY LIGHT WAS NOT FUNCTIONING ON THE POWER MODULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783787 ↗
• MalfunctionDec 8, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT POWER MODULE SHOWED A RED ALARM WHEN ATTACHED TO WALL OUTLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745554 ↗
• MalfunctionDec 5, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A HOSPITAL OWNED POWER MODULE (PM) WAS SENT TO TECH SERVICES FOR A REPAIR QUOTE. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725927 ↗
• MalfunctionNov 25, 2025Failure to Interrogate; Mechanical Problem; Improper or Incorrect Procedure or Method; Failure to Interrogate; Mechanical Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE BACKUP BATTERY WASN'T RECOGNIZED WHEN CONNECTED. IT ALSO APPEARED THAT THE POWER MODULE (PM) WAS DROPPED AND THE CASE WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649354 ↗
• MalfunctionNov 20, 2025Display or Visual Feedback Problem; Noise, Audible; Display or Visual Feedback Problem; Noise, Audible

  IT WAS REPORTED THAT THE BATTERY LEDS ON THE POWER MODULE DID NOT LIGHT UP. ADDITIONALLY, A CLICKING NOISE WAS HEARD WHENEVER THE UNIT WAS PLUGGED INTO POWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609889 ↗
• MalfunctionNov 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE POWER MODULE FOR INPATIENT USE APPEARED TO BE FUNCTIONAL WHEN CONNECTED TO THE HEARTMATE TOUCH AND SYSTEM CONTROLLER, BUT THE POWER MODULE SELF-TEST REPORTEDLY TOOK ABOUT TWICE AS LONG TO BEGIN WHEN HOLDING DOWN THE SILENCE ALARM BUTTON, AND EACH STEP WITHIN THE SELF-TEST TOOK TWICE AS LONG AS WELL. THE POWER MODULE APPEARED TO BE INCONSISTENT IN TURNING BACK ON AFTER DISCONNECTING AND RECONNECTING THE BACKUP BATTERY. THE MOST RECENT TEST OF RECONNECTING THE BACKUP BATTERY SAW NONE OF THE LIGHTS OR SOUNDS TURN ON, BUT IT STILL CONNECTED TO THE HEARTMATE TOUCH AND SYSTEM CONTROLLER. IT WAS LATER REPORTED THAT THE CAUSE OF THE PPM MALFUNCTION WAS STILL UNIDENTIFIABLE AND THAT THE ISSUES WERE INCONSISTENT. THERE WAS NO PATIENT INVOLVED WITH THE EVENT. THE PPM WAS RECEIVED BY ABBOTT FOR ANALYSIS ON 20OCT2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511681 ↗
• MalfunctionNov 6, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE POWER MODULE HAD A BROKEN BATTERY CONNECTOR. A REPLACEMENT WOULD BE SHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488252 ↗
• MalfunctionNov 4, 2025Material Discolored; Mechanical Problem; Failure to Power Up; Noise, Audible; Material Discolored; Mechanical Problem; Failure to Power Up; Noise, Audible

  IT WAS REPORTED THAT THE POWER MODULE WAS MAKING A CLICKING NOISE AND DID NOT POWER ON. DISCOLORATION WAS FOUND UNDERNEATH THE BATTERY, AND THE BATTERY CLIP WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469069 ↗
• MalfunctionOct 31, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE STREAMLINE CABLE ON THE POWER MODULE WAS DAMAGED. A REPLACEMENT STREAMLINE CABLE WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439041 ↗
• MalfunctionOct 29, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT POWER MODULE (PPM) HAD A CONSTANT YELLOW WRENCH. THE PPM WAS INTENDED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417912 ↗
• MalfunctionOct 27, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE POWER MODULE BATTERY CLIP BROKE AND NEEDED THE STREAMLINE CABLE TO REPAIR THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397303 ↗