HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET 2465Recalls & reported problems

Summary

The FDA's MAUDE database contains 259 adverse event reports that list this exact device (DI 00813024010692), received between Nov 14, 2018 and Feb 13, 2026 — classified as 18 injuries, 241 malfunctions.

The most frequently reported specific device problem is “Failure to Charge” (85 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 259 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT ABBOTT RECEIVED A SYSTEM CONTROLLER, 14V BATTERIES, 14V BATTERY CLIPS, AND A MOBILE POWER UNIT (MPU) CORD FOR AN UNKNOWN REASON. IT WAS SAID THE PATIENT ASSOCIATED WITH THESE DEVICES PASSED AWAY ON (B)(6) 2025. IT WAS UNCLEAR WHY THE DEVICES WERE SENT BACK AT THIS TIME. THE CAUSE OF DEATH WAS SAID TO BE DUE TO SEPSIS. THE PATIENT DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED. THE DEVICE OPERATED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332700 ↗
• MalfunctionFeb 10, 2026Failure to Charge

  IT WAS REPORTED THAT THE BATTERY HAD AN ERROR MESSAGE "B0013". THE BATTERY WAS UNABLE TO BE FULLY CHARGED AS THE UNIVERSAL BATTERY CHARGER (UBC) POCKET LIGHT WOULD TURN RED WHEN THE BATTERY WAS CHARGING MIDWAY. THE ISSUE PERSISTED WHEN THE AFFECTED BATTERY WAS TESTED TWICE AT THE TRANSPLANT OFFICE. THE BATTERY WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307457 ↗
• MalfunctionJan 26, 2026Corroded; Disconnection; Fire

  IT WAS REPORTED THAT THE CUSTOMER STATED THEY RECEIVED A CALL FROM A PATIENT WHO NOTED BURN MARKS ON A FEW OF THE CONTACTS ON ONE FOR THEIR 14V BATTERIES. NO POWER RELATED ALARMS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183027 ↗
• MalfunctionJan 2, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE 14V LITH-ION BATTERY HAD A RED LIGHT IN THE BATTERY CHARGER STRAIGHT OUT OF THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23948668 ↗
• MalfunctionDec 21, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PATIENT WAS GIVEN NEW BATTERIES THAT WERE CHECKED AND CLEANED. ONCE THE PATIENT GOT HOME, THERE WAS A RED LIGHT ON THE CHARGER. THE BATTERY WAS NEW OUT OF THE BOX AND DID NOT GET ANY USE. THE SITE HELPED TROUBLESHOOT THE ISSUE AND CONFIRMED IT WAS THE BATTERY. THERE WERE NO ALARMS OR ISSUES WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860420 ↗
• MalfunctionDec 9, 2025Failure to Charge; Mechanical Problem; Failure to Charge; Mechanical Problem

  IT WAS REPORTED THAT THE BATTERY WAS WET DUE TO LEAKAGE FROM THE SHOWER BAG. WHEN THE BATTERY WAS ATTEMPTED TO BE CHARGED, A RED LAMP WOULD ABOUT ABOUT ONCE A WEEK. THE SHOWER BAG AND BATTERY WERE EXCHANGED. THERE WAS NO INDICATION THAT THE BAG WAS IN INAPPROPRIATE USE AT THE TIME, AND NO DAMAGE TO THE SHOWER BAG WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23761364 ↗
• MalfunctionNov 21, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE BATTERY WOULD NOT CHARGE AND A B0013 ERROR CODE APPEARED. THE BATTERY WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617353 ↗
• MalfunctionNov 12, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT ACCORDING TO THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR, THE TEAM REPLACED A 14V BATTERY THEY PROVIDED TO THE PATIENT IN JANUARY. THE BATTERY NO LONGER CHARGED AND SHOWED A RED LIGHT ON THE UNIVERSAL BATTERY CHARGER (UBC). ERROR CODE B0001 SHOWED ON THE UBC. IT WAS STATED THAT THERE WERE NO DIRT OR DEBRIS NOTED, AND THE COPPER SECTION OF THE BATTERY WAS CLEANED WITH ALCOHOL, THE BATTERY WAS PLACED IN DIFFERENT POCKETS, MULTIPLE DIFFERENT UBC'S WERE TRIED, AND THE BATTERY WAS LEFT ON THE UBC FOR AN EXTENDED PERIOD OF TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536406 ↗
• InjuryNov 11, 2025Premature Discharge of Battery; Mechanical Problem; Premature Discharge of Battery; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT CALLED THE CLINIC WITH COMPLAINTS OF BATTERIES NOT HOLDING CHARGE. THE PATIENT ARRIVED AT CLINIC ON (B)(6) 2025 WITH NOTED DAMAGE TO 2 BATTERIES. THE 2 DAMAGED BATTERIES REPLACED, AND ALL CONNECTORS WERE CLEANED ON THE UNIVERSAL BATTERY CHARGER AND ALL BATTERIES. THE HEALTHCARE PROVIDER INDICATED THAT THE PATIENT EXPERIENCED A PRODUCT PROBLEM THAT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

  Patient problems: Insufficient Information

  MAUDE report 23526335 ↗
• InjuryNov 11, 2025Premature Discharge of Battery; Mechanical Problem; Premature Discharge of Battery; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT CALLED THE CLINIC WITH COMPLAINTS OF BATTERIES NOT HOLDING CHARGE. THE PATIENT ARRIVED AT CLINIC ON (B)(6) 2025 WITH NOTED DAMAGE TO 2 BATTERIES. THE 2 DAMAGED BATTERIES REPLACED, AND ALL CONNECTORS WERE CLEANED ON THE UNIVERSAL BATTERY CHARGER AND ALL BATTERIES. THE HEALTHCARE PROVIDER INDICATED THAT THE PATIENT EXPERIENCED A PRODUCT PROBLEM THAT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

  Patient problems: Insufficient Information

  MAUDE report 23526297 ↗
• MalfunctionOct 27, 2025Failure to Charge; Mechanical Problem; Failure to Charge; Mechanical Problem

  THERE WAS NO INDICATION THAT THE BAG WAS IN INAPPROPRIATE USE AT THE TIME, AND NO DAMAGE TO THE SHOWER BAG WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23395903 ↗
• MalfunctionOct 23, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT BATTERY WAS UNABLE TO FULLY CHARGE. THE AFFECTED BATTERY AS THE UNIVERSAL BATTERY CHARGER (UBC) POCKET LIGHT WOULD TURN RED WHEN THE BATTERY WAS CHARGING MID-WAY. ISSUE PERSISTED WHEN THE AFFECTED BATTERY WAS TESTED TWICE AT THE TRANSPLANT OFFICE. THE ALARM WAS B0003.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367171 ↗
• MalfunctionOct 20, 2025Corroded; Corroded

  IT WAS REPORTED THAT THE BATTERIES WERE TO BE RETURNED DUE TO CORRODED CONTACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341988 ↗
• MalfunctionOct 20, 2025Corroded; Corroded

  IT WAS REPORTED THAT THE BATTERY WAS RETURNED DUE TO CORRODED CONTACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341942 ↗
• MalfunctionOct 16, 2025Corroded; Corroded

  IT WAS REPORTED THAT TWO BATTERIES WERE EXCHANGED DUE TO CORROSION ON THE CONTACTS THAT CORRODED THE METAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319919 ↗
• MalfunctionOct 16, 2025Corroded; Corroded

  IT WAS REPORTED THAT TWO BATTERIES WERE EXCHANGED DUE TO CORROSION ON THE CONTACTS THAT CORRODED THE METAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319917 ↗
• MalfunctionSep 5, 2025Corroded; Disconnection; Corroded; Disconnection

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INTERMITTENT NOISE, WHICH THEY SUSPECTED TO HAVE BEEN CAUSED BY POOR CONTACT. THE INTERMITTENT NOISE HAD BEEN OCCURRING DURING USAGE. THERE WERE VISIBLE SIGNS OF CORROSION ON THE METAL PART OF THE BATTERY. A REPLACEMENT WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982497 ↗
• MalfunctionSep 5, 2025Corroded; Disconnection; Corroded; Disconnection

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INTERMITTENT NOISE, WHICH THEY SUSPECTED TO HAVE BEEN CAUSED BY POOR CONTACT. THE INTERMITTENT NOISE HAD BEEN OCCURRING DURING USAGE. THERE WERE VISIBLE SIGNS OF CORROSION ON THE METAL PART OF THE BATTERY. A REPLACEMENT WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982482 ↗
• MalfunctionAug 15, 2025Fire; Fire

  IT WAS REPORTED THAT A REPORT WAS MADE OF FAULTY EQUIPMENT, WITH THE UNIVERSAL BATTERY CHARGER (UBC) AND BATTERIES SMOLDERING. THE UBC LIGHTS ALL TURNED RED. EQUIPMENT WAS DISCONNECTED FROM MAINS AND ISOLATED. FIRE DEPARTMENT WAS CALLED TO ISOLATE EQUIPMENT. THE ACCOUNT DID THEIR OWN INTERNAL INVESTIGATION AND CONCLUDED THAT SALINE WAS SPILT INTO THE UBC, WHICH WAS BELIEVED TO BE THE CAUSE OF THE INCIDENT AS OPPOSED TO A FAULTY UBC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815939 ↗
• MalfunctionAug 15, 2025Fire; Fire

  IT WAS REPORTED THAT A REPORT WAS MADE OF FAULTY EQUIPMENT, WITH THE UNIVERSAL BATTERY CHARGER (UBC) AND BATTERIES SMOLDERING. THE UBC LIGHTS ALL TURNED RED. EQUIPMENT WAS DISCONNECTED FROM MAINS AND ISOLATED. FIRE DEPARTMENT WAS CALLED TO ISOLATE EQUIPMENT. THE ACCOUNT DID THEIR OWN INTERNAL INVESTIGATION AND CONCLUDED THAT SALINE WAS SPILT INTO THE UBC, WHICH WAS BELIEVED TO BE THE CAUSE OF THE INCIDENT AS OPPOSED TO A FAULTY UBC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815478 ↗
• MalfunctionAug 15, 2025Fire; Fire

  IT WAS REPORTED THAT A REPORT WAS MADE OF FAULTY EQUIPMENT, WITH THE UNIVERSAL BATTERY CHARGER (UBC) AND BATTERIES SMOLDERING. THE UBC LIGHTS ALL TURNED RED. EQUIPMENT WAS DISCONNECTED FROM MAINS AND ISOLATED. FIRE DEPARTMENT WAS CALLED TO ISOLATE EQUIPMENT. THE ACCOUNT DID THEIR OWN INTERNAL INVESTIGATION AND CONCLUDED THAT SALINE WAS SPILT INTO THE UBC, WHICH WAS BELIEVED TO BE THE CAUSE OF THE INCIDENT AS OPPOSED TO A FAULTY UBC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815450 ↗
• MalfunctionAug 15, 2025Fire; Fire

  IT WAS REPORTED THAT A REPORT WAS MADE OF FAULTY EQUIPMENT, WITH THE UNIVERSAL BATTERY CHARGER (UBC) AND BATTERIES SMOLDERING. THE UBC LIGHTS ALL TURNED RED. EQUIPMENT WAS DISCONNECTED FROM MAINS AND ISOLATED. FIRE DEPARTMENT WAS CALLED TO ISOLATE EQUIPMENT. THE ACCOUNT DID THEIR OWN INTERNAL INVESTIGATION AND CONCLUDED THAT SALINE WAS SPILT INTO THE UBC, WHICH WAS BELIEVED TO BE THE CAUSE OF THE INCIDENT AS OPPOSED TO A FAULTY UBC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815409 ↗
• MalfunctionJul 31, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PATIENT HAD A DEFECTIVE BATTERY. THERE WAS A RED LIGHT WHILE THE BATTERY WAS IN THE UNIVERSAL BATTERY CHARGER. THE BATTER WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680894 ↗
• MalfunctionJul 28, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT TWO OF THE PATIENT'S BATTERY TERMINALS WERE DAMAGED. THE DAMAGE CREATED A HOLE IN THE BATTERY TERMINAL OF BOTH PATIENT'S BATTERIES. THE PATIENT DID NOT REPORT A NOTABLE EVENT THAT CAUSED THE DAMAGE AND THE BATTERIES WERE STORED IN THE PATIENT'S BACKUP BAG. THE CAUSE OF DAMAGE WAS UNKNOWN. THERE WAS NO DAMAGE TO THE CONSOLIDATED BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637721 ↗
• MalfunctionJul 28, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT TWO OF THE PATIENT'S BATTERY TERMINALS WERE DAMAGED. THE DAMAGE CREATED A HOLE IN THE BATTERY TERMINAL OF BOTH PATIENT'S BATTERIES. THE PATIENT DID NOT REPORT A NOTABLE EVENT THAT CAUSED THE DAMAGE AND THE BATTERIES WERE STORED IN THE PATIENT'S BACKUP BAG. THE CAUSE OF DAMAGE WAS UNKNOWN. THERE WAS NO DAMAGE TO THE CONSOLIDATED BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629983 ↗