THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY 106128Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00813024011255), received between Feb 8, 2019 and Sep 25, 2026 — classified as 4 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Electrical Power Problem” (14 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Failure to Charge

  It was reported that the 11-volt Backup Battery was showing "no charge". Trouble shooting included the clinic checking it and then replacing it.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899286 ↗
• MalfunctionSep 25, 2026Contamination /Decontamination Problem

  It was reported that there was sticky substance under the System Controller Battery. Log Files were sent for review. There were no unusual events recorded in the Log Files. The device operated as expected. There were no known alarms. The patient was due of 11V Battery replacement, and the issue was noticed upon opening the back cover. The System Controller and Battery were replaced. The event resolved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897927 ↗
• MalfunctionMar 4, 2026Electrical Power Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A BACKUP BATTERY WITH A YELLOW WRENCH OCCURRED RIGHT AFTER THE EXCHANGE. NEW BACKUP BATTERY WAS ORDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508767 ↗
• MalfunctionJan 24, 2025Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH A COMPLAINT OF A BACKUP BATTERY (EBB) FAULT. THE EBB WAS THEN REPLACED WITH A NEW EBB FROM THE SHELF, BUT THE ALARM DID NOT RESOLVE. THE ORIGINAL BACKUP BATTERY WAS THEN REINSERTED AND THE ALARM RESOLVED. THE ORIGINAL EBB HAD 11 MONTHS REMAINING. LOG FILES WERE SENT FOR REVIEW. THE LOG FILE BEGAN CAPTURING EBB FAULTS ON (B)(6) 2025 DUE TO THE EBB FAILING THE LOAD TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230716 ↗
• MalfunctionJan 20, 2025Mechanical Problem; Device Difficult to Setup or Prepare; Mechanical Problem; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE BACKUP BATTERY (EBB) WAS TAKEN OUT OF BOX AND WOULD NOT ENGAGE WITH THE SYSTEM CONTROLLER. AFTER INSPECTION, THEY FOUND THAT IT WAS DUE TO A BENT PIN IN THE EBB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191721 ↗
• MalfunctionJan 16, 2025Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE BACKUP BATTERY (EBB) WAS USED IN AN EXISTING SYSTEM CONTROLLER AND IMMEDIATELY HAD AN EBB FAULT ALARM. THE EBB WAS USED IN ANOTHER SYSTEM CONTROLLER AND THE SAME ALARM OCCURRED. A SELF-TEST DID NOT CLEAR THE ALARM AND THE EBB WAS REPLACED. THE EBB HAD NOT YET BEEN ISSUED TO A PATIENT. THE EBB WAS INITIALLY BEING CHARGED FOR USE WHEN THE EBB FAULT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172388 ↗
• MalfunctionJan 9, 2025Mechanical Problem; Device Difficult to Setup or Prepare; Mechanical Problem; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PATIENT CALLED THE CLINIC TO REPORT THAT THEY RECEIVED AN INTERMITTENT ALARM ON THEIR SYSTEM CONTROLLER. UPON INTERROGATION, THE CONTROLLER ALARM WAS FOUND TO BE A "BACKUP BATTERY FAULT". DUE TO THEM NOT BEING ABLE TO FIND TRANSPORTATION TO THE CLINIC, THE PATIENT THEN SILENCED THEIR ALARM AND A HEALTH NURSE WENT OVER TO EXCHANGE THE SYSTEM CONTROLLER. THE HOME HEALTH NURSE SUCCESSFULLY EXCHANGED THE PATIENT'S PRIMARY CONTROLLER TO THEIR BACKUP CONTROLLER. THE PATIENT DID EXPERIENCE QUITE A BIT OF ANXIETY FROM THIS EXCHANGE. THE EXCHANGED CONTROLLER WAS RETURNED TO THE CLINIC FOR FURTHER EVALUATION AND WAS RECEIVED ON (B)(6) 2024. THE OLD BATTERY WAS REMOVED AND EXCHANGED FOR A BRAND-NEW BATTERY. THE DATE AND CLOCK WERE SET IN ACCORDANCE WITH PROTOCOL. HOWEVER, A BACKUP BATTERY FAULT ALARM WAS STILL DISPLAYING ON THE ORIGINAL CONTROLLER THAT WAS RECEIVED BY THE CLINIC. THE BATTERY WAS REMOVED AND RESEATED FOR AN ADDITIONAL TIME, HOWEVER THERE WAS DIFFICULTY IN GETTING THE WIRING PLATE TO SIT SURFACE WITH THE BATTERY ITSELF. THE CONTROLLER WAS POWERED DOWN AND THEN REPOWERED BACK UP WITH A RETURN OF THE BACKUP BATTERY FAULT ALARM. THEREFORE, IT APPEARED TO B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117788 ↗
• MalfunctionOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE BACKUP BATTERY WAS RECEIVED FOR EVALUATION. NO INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20429233 ↗
• MalfunctionOct 11, 2024Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT DURING PREPARATION OF THE HEARTMATE 3 PUMP IMPLANTATION, THE BACKUP BATTERY IN THE SYSTEM CONTROLLER ALERTED "BACKUP BATTERY FAULT ALARM". THE ALARM WOULD NOT CLEAR AFTER ATTEMPTING TO DISCONNECT AND RECONNECT BACKUP BATTERY, THEREFORE IT WAS REPLACED. EXCHANGING THE BACKUP BATTERY RESOLVED THE BACKUP BATTERY FAULT ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20426047 ↗
• MalfunctionApr 17, 2024Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT HAD THREE BATTERY FAULTS OVER THE LAST 5 MONTHS. LOG FILES CAPTURED BACKUP BATTERY FAULT ALARMS ON (B)(6) 2024 DUE TO THE EBB FAILING THE LOAD TEST. THE PATIENT HAD A LOW INTERNATIONAL NORMALIZED RATIO (INR) DUE TO A GASTROINTESTINAL (GI) BLEED. THEY WERE UNWILLING TO RISK A STROKE FROM A SYSTEM CONTROLLER EXCHANGE, SO THEY OPTED FOR AN EMERGENCY BACKUP BATTERY (EBB) EXCHANGE. THE NEW EBB DID NOT WORK THE FIRST TIME USING IT AND PRODUCED A BACKUP BATTERY FAULT ALARM. A DIFFERENT EBB WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19124086 ↗
• MalfunctionMar 19, 2024Corroded; Corroded

  IT WAS REPORTED THAT A TEAR IN BEND RELIEF WAS NOTED WITH NO WIRES EXPOSED OR ALARMS. THIS WAS ON THE DISTAL END OF THE DRIVELINE TO THE SYSTEM CONTROLLER. THERE WAS NO EVIDENCE OF ANY TYPE OF DRIVELINE ELECTRICAL CONDUCTOR ISSUE IN THE LOG FILE. THE TEAR TO THE PERCUTANEOUS LEAD OUTER JACKET APPEARED COSMETIC ONLY. IT WAS ALSO NOTED POSSIBLE GREEN SUBSTANCE (CORROSION) OR POSSIBLE WATER DAMAGE IN THE CONTROLLER. THE CONTROLLER WAS OPERATING NORMALLY. ADDITIONAL INFORMATION STATED THAT RESCUE TAPE WAS APPLIED TO THE DAMAGED DRIVELINE. THE CONTROLLER WAS EXCHANGED DUE TO WATER DAMAGE PRESENT ON THE SCREEN AND CORROSION OF INTERNAL 11-VOLT BATTERY. RELATED DRIVELINE DAMAGE IS REPORTED UNDER MANUFACTURER REPORT NUMBER 2916596-2024-01343. RELATED CONTROLLER IS REPORTED UNDER MANUFACTURER REPORT NUMBER 2916596-2024-01344.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935736 ↗
• MalfunctionOct 4, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS HAVING CONSISTENT EXTERNAL BACKUP BATTERY (EBB) FAULTS. THE BACKUP BATTERY WAS RESEATED WITH NO RESOLUTION OF ALARMS. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ALARMS RESOLVED. RELATED MFR. REPORT # 2916596-2023-04634.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17870896 ↗
• MalfunctionAug 31, 2023Mechanical Problem; Manufacturing, Packaging or Shipping Problem; Mechanical Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT UPON REMOVING THE BACKUP BATTERY FROM THE BOX, BENT PINS WERE NOTED. THERE WERE NO ALARMS, AND THE BATTERY WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17665486 ↗
• MalfunctionAug 28, 2023Mechanical Problem; Device Difficult to Setup or Prepare; Mechanical Problem; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT, WHEN THE CARE PROVIDER ATTEMPTED TO PLUG IN THE EMERGENCY BACKUP BATTERY (EBB) INTO THE CONTROLLER, THE CONNECTION DID NOT FIT. UPON INSPECTION, A BENT PIN WAS FOUND ON THE RIGHT SIDE OF THE EBB. A NEW EBB WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17631638 ↗
• MalfunctionAug 18, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE WHITE PLASTIC WRAP OF THE 11VOLT LITHIUM-ION BATTERY WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573370 ↗
• MalfunctionApr 6, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT'S EMERGENCY BACKUP BATTERY (EBB) WAS EXCHANGED AND FOUND TO BE LEAKING ACID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690309 ↗
• MalfunctionJan 25, 2022Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC FOR A ROUTINE BACKUP BATTERY EXCHANGE DUE TO EXPIRATION. THE NEW BACKUP BATTERY OUT OF BOX TRIGGERED A BACKUP BATTERY FAULT ALARM. THIS HAPPENED WITH 2 ADDITIONAL OUT OF BOX BACKUP BATTERIES. THE FOURTH BACKUP BATTERY INSTALLED WORKED WITHOUT ISSUE. ADDITIONAL INFORMATION REPORTED THAT 2 OF THE BATTERIES HAD BENT PINS OUT OF BOX. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2022-00487 & 2916596-2022-00486.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13345205 ↗
• MalfunctionJan 25, 2022Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC FOR A ROUTINE BACKUP BATTERY EXCHANGE DUE TO EXPIRATION. THE NEW BACKUP BATTERY OUT OF BOX TRIGGERED A BACKUP BATTERY FAULT ALARM. THIS HAPPENED WITH 2 ADDITIONAL OUT OF BOX BACKUP BATTERIES. THE FOURTH BACKUP BATTERY INSTALLED WORKED WITHOUT ISSUE. ADDITIONAL INFORMATION REPORTED THAT 2 OF THE BATTERIES HAD BENT PINS OUT OF BOX. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2022-00489.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13345050 ↗
• MalfunctionJan 25, 2022Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC FOR A ROUTINE BACKUP BATTERY EXCHANGE DUE TO EXPIRATION. THE NEW BACKUP BATTERY OUT OF BOX TRIGGERED A BACKUP BATTERY FAULT ALARM. THIS HAPPENED WITH 2 ADDITIONAL OUT OF BOX BACKUP BATTERIES. THE FOURTH BACKUP BATTERY INSTALLED WORKED WITHOUT ISSUE. ADDITIONAL INFORMATION REPORTED THAT 2 OF THE BATTERIES HAD BENT PINS OUT OF BOX.. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2022-00487 & 2916596-2022-00489.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13344637 ↗
• MalfunctionJan 20, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE EQUIPMENT MANGER CHECKED THE EQUIPMENT AND NOTICED A PIECE OF THE METAL ON ONE OF THE BATTERY'S TERMINALS WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306652 ↗
• MalfunctionJan 17, 2022No Apparent Adverse Event; No Apparent Adverse Event

  RELATED MANUFACTURING REPORT NUMBER: 2916596-2021-06813. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "REPLACE SYSTEM CONTROLLER" ALARM AT HOME. THEY THEN PRESENTED THEMSELVES TO THE CLINIC FOR A SYSTEM CONTROLLER EXCHANGE. ADDITIONAL INFORMATION REVEALED THE CUSTOMER'S REPORT OF A CONTROLLER FAULT ALARM FOLLOWING DRIVELINE REPAIR AS WELL AS EVIDENCE OF INTERNAL DRIVELINE DAMAGE; A SEPARATION OF THE WIRE RIBBON WITHIN THE CONTROLLER. A REVIEW OF THE LOG FILES REVEALED A MOMENTARY REPLACE CONTROLLER EVENT ON (B)(6) 2021 AT 1032 WHICH WAS ASSOCIATED WITH A BACKUP BATTERY TEST CIRCUIT FAULT. ADDITIONALLY, THEY REPORTED THE CONTROLLER PASSED ANOTHER SELF-TEST IN THE CLINIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266415 ↗
• MalfunctionDec 10, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT UPON INSPECTION OF BATTERY A BROKEN PIN WAS FOUND. THIS INSPECTION WAS DONE OUT OF BOX AND IT WAS PRIOR TO IT BEING ASSIGNED TO A PATIENT. A REQUEST FOR A REPLACEMENT WAS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12979049 ↗
• MalfunctionDec 9, 2021Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PATIENT'S PRIMARY CONTROLLER'S EMERGENCY BACKUP BATTERY (EBB) WAS UNABLE TO CHARGE SINCE LEFT VENTRICLE ASSIST DEVICE (LVAD) IMPLANTATION. EBB WAS RESEATED WITHOUT RESOLUTION. THE DEFECTIVE EBB WAS EXCHANGED WITH A NEW EBB. THE NEW BATTERY WAS ABLE TO CHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12972526 ↗
• MalfunctionOct 11, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT CALLED BECAUSE THEY COULD NOT PERFORM A SELF-TEST ON THEIR SYSTEM CONTROLLER AND THE SCREEN ON THEIR SYSTEM CONTROLLER TURNED YELLOW. THE PATIENT'S SYSTEM CONTROLLER WAS REPLACED. IT WAS ALSO REPORTED THAT THE WAS YELLOW LIQUID FOUND IN THE BATTERY COMPARTMENT WHEN THE BACKUP BATTERY WAS ASSESSED. THE PRODUCT WAS RETURNED WAS EVALUATION. RELATED MANUFACTURER'S REFERENCE NUMBER: 2916596-2021-05383.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12611422 ↗
• MalfunctionSep 9, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE EMERGENCY BACKUP BATTERY (EBB) OUT OF BOX HAD VISIBLE BENT PINS BEFORE BEING PLACED IN THE SYSTEM CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450124 ↗