HeartMate® Sealed Lead Acid Battery 109200Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00813024012566), received between Apr 27, 2020 and Dec 23, 2025 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (24 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Failure to Charge; No Apparent Adverse Event; Failure to Charge; No Apparent Adverse Event

  IT WAS REPORTED THAT THE POWER MODULE BACKUP BATTERY NEEDED TO BE REPLACED DUE TO UNEVEN BATTERY CHARGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880751 ↗
• MalfunctionDec 23, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE POWER MODULE BACKUP BATTERY NEEDED TO BE REPLACED DUE TO UNEVEN BATTERY CHARGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880589 ↗
• MalfunctionNov 13, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE POWER MODULE (PPM) WAS UNRESPONSIVE TO AC POWER. THE UNIT BEEPED ONCE WHEN THE BACKUP BATTERY WAS CONNECTED. THE PATIENT WAS EXCHANGED TO A NEW PPM BACKUP BATTERY FROM THE HOSPITAL AND FROM ABBOTT CUSTOMER SERVICE, NEITHER OF WHICH CLEARED THE ALARM. THE POWER MODULE WAS EXCHANGED. IT WAS LATER REPORTED THE REPLACEMENT BACKUP BATTERY EXPERIENCED AN OUT OF BOX FAILURE. IT WAS LATER REPORTED THAT THE LOANER PPM LENT TO THE PATIENT BY THE HOSPITAL WAS RETURNED BACK TO THE HOSPITAL'S INVENTORY WHERE IT WAS VERIFIED TO BE FULLY FUNCTIONAL WITH OTHER BATTERIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23545679 ↗
• MalfunctionOct 29, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS DAMAGE TO THE POWER MODULE BATTERY. THE BATTERY WOULD BE EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420760 ↗
• MalfunctionJun 5, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT INSPECTION OF THE POWER MODULE (PM) REVEALED A POSSIBLE ACID LEAK FROM INTERNAL BATTERY AND EVIDENCE OF LEAK AROUND THE BATTERY CLAMP SEEPING INTO THE PM. THE UNIT WAS REMOVED FROM USE AND SEGREGATED PENDING EXAMINATION AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152501 ↗
• MalfunctionMay 22, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR WAS NOTIFIED BY THE BIOMED THAT WHEN EXCHANGING THE POWER MODULE BACKUP BATTERIES DURING PREVENTATIVE MAINTENANCE, TWO POWER MODULE BACKUP BATTERIES FAILED OUT OF THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075494 ↗
• MalfunctionMay 22, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR WAS NOTIFIED BY THE BIOMED THAT WHEN EXCHANGING THE POWER MODULE BACKUP BATTERIES DURING PREVENTATIVE MAINTENANCE, TWO POWER MODULE BACKUP BATTERIES FAILED OUT OF THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075492 ↗
• MalfunctionFeb 21, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT MAINTENANCE WAS PERFORMED ON AN EDUCATION POWER MODULE, BUT THE NEXT DAY IT WAS ALARMING. TROUBLESHOOTING WAS PERFORMED AND THE BATTERY WAS RESEATED BUT IT DID NOT RESOLVE THE ISSUE. THE POWER MODULE WAS REPLACED. IT WAS LATER REPORTED THAT THE POWER MODULE WAS NO LONGER ATTACHED TO A PATIENT AT THE TIME OF THE EVENT AND WAS STRICTLY BEING USED FOR EDUCATIONAL PURPOSES. IT WAS NOTED THAT THE 12V BATTERY PLACED IN THE POWER MODULE WAS FAULTY AND IT WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434719 ↗
• MalfunctionJan 8, 2025Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION WAS PROVIDED THAT WHEN THE BATTERY WAS CONNECTED, A RED BATTERY SYMBOL LIT UP. TROUBLESHOOTING WAS PERFORMED BY CHARGING THE BATTERY WHICH DID NOT WORK. THEREFORE, THE BATTERY WAS EXCHANGED WHICH SUCCESSFULLY REPAIRED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106208 ↗
• MalfunctionJan 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE POWER MODULE WAS CORRECTLY CONNECTED TO AC POWER AND SHOWED GREEN SYMBOLS. THE POWER MODULE ALARMED AND THE BATTERY SYMBOLS TURNED RED. THE BATTERY STATUS AND CONNECTIONS WERE CHECKED AND NO ABNORMALITIES WERE DETECTED. THE BATTERY WAS DEPLETED AND NEEDED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067604 ↗
• MalfunctionDec 13, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE YELLOW WRENCH LAMP AND THE RED BATTERY ALARM LAMP ILLUMINATED WHEN THE BUILT-IN POWER MODULE (PM) BATTERY PURCHASED FOR PERIODIC REPLACEMENT WAS REPLACED AND SWITCHED TO BATTERY DRIVE. THE BUILT-IN BATTERY WAS NOT USED BECAUSE THE REPRODUCIBILITY WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926469 ↗
• MalfunctionDec 11, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE YELLOW WRENCH LAMP AND THE RED BATTERY ALARM LAMP ILLUMINATED WHEN THE BUILT-IN POWER MODULE BATTERY PURCHASED FOR PERIODIC REPLACEMENT WAS REPLACED AND SWITCHED TO BATTERY DRIVE. THE BUILT-IN BATTERY WAS NOT USED BECAUSE THE REPRODUCIBILITY WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909479 ↗
• MalfunctionOct 21, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE NEW POWER MODULE BATTERY WAS NOT WORKING. THE BATTERY WAS DISCONNECTED FOR 10+ MINUTES AND RECONNECTED, A SYSTEM TEST WAS ATTEMPTED, HOWEVER THE RED BATTERY AND YELLOW WRENCH ALARMS STILL SHOWED. THE POWER MODULE BACKUP BATTERY WAS EXCHANGED. IT WAS ADDITIONALLY REPORTED THAT THE SERIAL NUMBER OF THE POWER MODULE WAS UNKNOWN AS THE CLINIC HAD RECEIVED 5 NEW POWER MODULES AND THE POWER MODULE WAS NOT CONNECTED TO A PATIENT. IT WAS NOTED THAT ALL OF THE POWER MODULES NOW HAD WORKING BATTERIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495284 ↗
• MalfunctionOct 9, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AFTER PERIODIC REPLACEMENT OF THE POWER MODULE BACKUP BATTERY ON 17SEP2024, THE BATTERY STARTED TO BE CHARGED BY THE POWER MODULE. HOWEVER, THE RED LAMP REMAINED, SO A REPLACEMENT WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408838 ↗
• MalfunctionOct 2, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE BATTERY WAS EXCHANGED AND THE ALARM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353742 ↗
• MalfunctionSep 10, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A BATTERY ERROR ALARMED RELATED TO THE POWER MODULE. RED BATTERY SYMBOL LIT UP. PICTURED WERE SUBMITTED FOR REVIEW. THE BATTERY WAS REPLACED, AND THE ALARM RESOLVED. THE DEFECTIVE BATTERY WOULD BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184730 ↗
• MalfunctionAug 21, 2024Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PATIENT WAS TRAVELING ACROSS THE COUNTRY AND ATTEMPTED TO PLUG THE POWER MODULE INTO THE AUXILIARY JACK OF THEIR TRUCK WITH THE ABBOTT CAR ADAPTER. DESPITE THE POWER MODULE BEING PLUGGED INTO THE AUXILIARY JACK, THE POWER MODULE'S BACKUP BATTERY WAS NOT CHARGING ( (B)(6) ) AND DISCHARGED (DIED). THE DISCHARGED BACKUP BATTERY WAS REPLACED WITH A NEW BACKUP BATTERY ( (B)(6) ) WHICH ALSO WOULD NOT CHARGE. THE PATIENT MADE MULTIPLE ATTEMPTS TO REINSTALL THE BACKUP BATTERY AND CALLED THE SITE TO ATTEMPT TROUBLESHOOTING. THE REPLACEMENT BACKUP BATTERY ( (B)(6) ) STILL WOULD NOT CHARGE WITH TROUBLESHOOTING AND THE PATIENT WAS SENT ANOTHER REPLACEMENT BACKUP BATTERY BY CUSTOMER SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015607 ↗
• MalfunctionAug 8, 2024Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR TRIED TO INSERT THE POWER MODULE BACKUP BATTERY WITH THE SERIAL NUMBER (B)(6) INTO THE POWER MODULE AND WAS CONFRONTED WITH YELLOW WRENCH AND RED HAZARD SYMBOL ALARMS. WHEN THE BACKUP BATTERY WAS DISCONNECTED AND RESEATED THE ALARMS PERSISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939950 ↗
• MalfunctionJul 30, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE POWER MODULE ALARMED WITH RED BATTERY. THE BATTERY WAS TO BE REPLACED VIA PREVENTIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19862275 ↗
• MalfunctionJul 24, 2024Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT THE POWER MODULE WAS DISCONNECTED, AND THE INTERNAL BATTERY WAS INSTALLED WITHOUT PROBLEM. AFTER INSTALLING THE BATTERY, THE POWER MODULE'S POWER CABLE WAS CONNECTED AND AFTER THREE MINUTES THE BATTERY SYMBOL TURNED RED, AND AN AUDIBLE ALARM SOUNDED. THE POWER CORD WAS CHANGED, THEN TURNED OFF AND ON AGAIN. THE BATTERY WAS INSTALLED IN A NEW POWER MODULE AND THE BATTERY SYMBOL CONTINUED TO APPEAR IN RED. THE EQUIPMENT POWER MODULES WERE TESTED WITH A NEW BATTERY AND THE ALERT WAS RESOLVED. IT WAS LATER NOTICED THAT THE BLACK CABLE THAT INTERNALLY CONNECTS THE BATTERY WAS BROKEN IN THE FIXING AREA WHICH GENERATED POOR CONTACT, THE INSTALLATION OF THIS BATTERY WAS TESTED IN AN ABBOTT-OWNED MODULE, AND IT DID NOT WORK. NO ALARM OCCURRED. THE PATIENT REPLACED THE BLACK CABLE WITH ANOTHER ONE AND THE BATTERY WAS INSTALLED AGAIN WITHOUT ANY ALARMS. THE BATTERY WOULD BE TRACKED AND WOULD NOT BE SHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19820598 ↗
• MalfunctionJul 24, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT IN THE NON-CLINICAL ENVIRONMENT, THE SALES UNPACKED THE POWER MODULE, AND AFTER INSTALLING THE BACKUP BATTERY AND CONNECTING THE POWER CABLE, THE POWER MODULE LIT UP WITH A RED BATTERY ALARM. THE BATTERY HAD TO BE REPLACED WITH ANOTHER BACKUP BATTERY TO ELIMINATE THE ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819770 ↗
• MalfunctionJul 16, 2024Use of Device Problem; No Apparent Adverse Event; Use of Device Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE NEW POWER MODULE BATTERY WAS NOT WORKING. THE BATTERY WAS DISCONNECTED FOR 10+ MINUTES AND RECONNECTED, A SYSTEM TEST WAS ATTEMPTED, HOWEVER THE RED BATTERY AND YELLOW WRENCH ALARMS STILL SHOWED. THE POWER MODULE BACKUP BATTERY WAS EXCHANGED. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT'S SPOUSE EXCHANGED THEIR SYSTEM CONTROLLER DUE TO AN ALARM. IT WAS UNCLEAR WHAT THE ALARM WAS AS THEY IMMEDIATELY PANICKED AND SWITCHED OUT THE SYSTEM CONTROLLER WITHOUT CALLING THE CLINIC. THE PATIENT'S SPOUSE WAS UNABLE TO FULLY CONNECT THE DRIVELINE TO THE BACKUP SYSTEM CONTROLLER AS THEY COULD NOT GET IT TO LOCK. THE PATIENT BECAME UNRESPONSIVE AND WENT INTO CARDIAC ARREST DUE TO THE PUMP BEING OFF DUE TO THE DRIVELINE BEING UNABLE TO BE RECONNECTED TO THE SYSTEM CONTROLLER. IT WAS NOTED THAT OVER THE PHONE THE CLINIC WAS ABLE TO WALK THE SPOUSE THROUGH THE STEPS TO RESOLVE THE ISSUE. UPON ARRIVAL TO THE EMERGENCY DEPARTMENT, IT WAS READING "REPLACE SYSTEM MONITOR" AND IT WAS EXCHANGED. THROUGH FURTHER INVESTIGATION IT WAS FOUND THAT THE PATIENT WAS STILL ON THEIR ORIGINAL SYSTEM CONTROLLER. IT WAS ASSUMED THAT THE ALARM AT HOME MAY HAVE BEEN A REPLACE SYSTEM CONTROLLER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755671 ↗
• MalfunctionJul 10, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A NEWLY OPENED POWER MODULE WAS TURNED ON FOR AN INITIAL TEST RUNNING. ONCE TURNED ON, THERE WAS A RED LIGHT BATTERY ALARM IN THE FRONT OF THE POWER MODULE. THE BACKUP BATTERY WAS PROPERLY INSERTED WITH PROPER WALL POWER SUPPLY. ANOTHER BACKUP BATTERY WAS INSERTED FOR A TEST AND IT WORKED FINE. THE NEW BATTERY WAS TO BE USED BUT THE PRODUCT WAS REPORTED TO BE AN OUT OF BOX FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715760 ↗
• MalfunctionJul 8, 2024Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE POWER MODULE'S BACKUP BATTERY WAS NOT CHARGING. THE BACKUP BATTERY WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697844 ↗
• MalfunctionJun 10, 2024Use of Device Problem; Electrical Power Problem; Use of Device Problem; Electrical Power Problem

  IT WAS REPORTED THAT DURING THE PERIODIC INSPECTION OF POWER MODULE, WHEN REPLACING THE INTERNAL BATTERY, THE RED LAMP WAS LIT, REGARDLESS OF WHETHER IT WAS REPEATED OR CONNECTED TO ANOTHER POWER MODULE. ONE POWER MODULE INTERNAL BATTERY WOULD BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506066 ↗