SynCardia Freedom® Onboard Battery 295025-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00858000003084), received between Dec 8, 2017 and Sep 16, 2026 — classified as 2 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (50 reports).

5 other recalls cover devices cleared under the same FDA submission (P030011); they may or may not involve this specific model.

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 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Charging Problem

  Per hospital staff, Freedom Onboard Battery S/N (b)(6) will not charge. Battery has been placed in multiple charging ports on charger and reportedly will not charge. No adverse impact to patient reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790148 ↗
• MalfunctionMar 3, 2026Charging Problem; Output Problem

  PER HOSPITAL STAFF, ONBOARD BATTERY WILL NOT HOLD A CHARGE OR FUNCTION IN A FREEDOM DRIVER. DEVICE WAS NOT IN PATIENT USE AT TIME OF COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500016 ↗
• MalfunctionFeb 18, 2026Output Problem

  PER HOSPITAL STAFF, ONE OF THE ONBOARD FREEDOM DRIVER BATTERIES THAT CAME IN THE DISCHARGE KIT HAS THE ISSUE WHERE IT SHOWS AS BEING FULLY CHARGED BUT WILL NOT TURN ON A DRIVER. THE ISSUE IS WITH BATTERY SN (B)(6). BATTERY NOT IN PATIENT USE AT TIME OF COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379352 ↗
• MalfunctionFeb 12, 2026Charging Problem

  PER HOSPITAL STAFF, PATIENT WAS SEEN IN THE CLINIC AND BROUGHT TWO FREEDOM DRIVER BATTERIES AND STATED THAT THEY WILL NOT CHARGE. NO ADVERSE IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326453 ↗
• MalfunctionFeb 11, 2026Charging Problem

  PER HOSPITAL STAFF, PATIENT WAS SEEN IN THE CLINIC AND BROUGHT TWO FREEDOM DRIVER BATTERIES AND STATED THAT THEY WILL NOT CHARGE. NO ADVERSE IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317740 ↗
• MalfunctionSep 23, 2024Battery Problem; Battery Problem

  PER DISTRIBUTOR, BATTERIES ARE DEFECTIVE. NO REPORTED ADVERSE IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20288078 ↗
• MalfunctionSep 18, 2024Battery Problem; Battery Problem

  PER DISTRIBUTOR, BATTERIES ARE DEFECTIVE. NO REPORTED ADVERSE IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249086 ↗
• MalfunctionSep 18, 2024Battery Problem; Battery Problem

  PER DISTRIBUTOR, BATTERIES ARE DEFECTIVE. NO ADVERSE IMPACT TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248919 ↗
• MalfunctionSep 18, 2024Battery Problem; Battery Problem

  PER DISTRIBUTOR, BATTERIES ARE DEFECTIVE. NO REPORTED ADVERSE IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248588 ↗
• MalfunctionOct 21, 2022Battery Problem; Battery Problem

  THE REPORTED ISSUES INVOLVE THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER THREE SEPARATE MEDICAL DEVICE REPORTS: (1) FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2022-00109); (2) FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2022-00110); (3) FREEDOM BATTERY CHARGER S/N (B)(4)). THE FREEDOM ONBOARD BATTERIES AND FREEDOM BATTERY CHARGER WERE NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THE FREEDOM BATTERY CHARGER DID NOT CHARGE ANY FREEDOM ONBOARD BATTERIES. ADDITIONALLY, TWO FREEDOM ONBOARD BATTERIES WERE UNABLE TO CHARGE. THE CUSTOMER IS UNCLEAR IF THESE ISSUES ARE RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15652020 ↗
• MalfunctionOct 21, 2022Battery Problem; Battery Problem

  DURING ROUTINE EVALUATION, A SYNCARDIA TECHNICIAN REPORTED THAT THE FREEDOM ONBOARD BATTERY SYSTEM MANAGEMENT (SMBUS) DATA WAS NOT ACTIVE WITHOUT POWER, THE CHARGE INDICATOR LEDS DID NOT ILLUMINATE WITHOUT POWER AND THE BATTERY DID NOT POWER A FREEDOM DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15651930 ↗
• MalfunctionOct 19, 2022Battery Problem; Battery Problem

  THE REPORTED ISSUES INVOLVE THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER THREE SEPARATE MEDICAL DEVICE REPORTS: (1) FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2022-00109); (2) FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2022-00110); (3) FREEDOM BATTERY CHARGER S/N (B)(4)). THE FREEDOM ONBOARD BATTERIES AND FREEDOM BATTERY CHARGER WERE NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THE FREEDOM BATTERY CHARGER DID NOT CHARGE ANY FREEDOM ONBOARD BATTERIES. ADDITIONALLY, TWO FREEDOM ONBOARD BATTERIES WERE UNABLE TO CHARGE. THE CUSTOMER IS UNCLEAR IF THESE ISSUES ARE RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15631917 ↗
• MalfunctionOct 13, 2022Battery Problem; Battery Problem

  THE FREEDOM ONBOARD BATTERY WAS NOT SUPPORTING A PATIENT AT THE TIME OF THE EVENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT DURING A TRAINING EVENT THE FREEDOM ONBOARD BATTERY DID NOT HAVE A CHARGE. THE HOSPITAL ATTEMPTED TO CHARGE THE BATTERY WITHOUT SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598825 ↗
• MalfunctionOct 13, 2022Battery Problem; Battery Problem

  THE FREEDOM ONBOARD BATTERY WAS NOT SUPPORTING A PATIENT AT THE TIME OF THE EVENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT DURING A TRAINING EVENT THE FREEDOM ONBOARD BATTERY DID NOT HAVE A CHARGE. THE HOSPITAL ATTEMPTED TO CHARGE THE BATTERY WITHOUT SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598762 ↗
• MalfunctionSep 7, 2022Battery Problem; Battery Problem

  THE FREEDOM ONBOARD BATTERY WAS NOT SUPPORTING A PATIENT AT THE TIME OF THE EVENT. THE CUSTOMER, A (B)(6) HOSPITAL, REPORT THAT THE FREEDOM ONBOARD BATTERY DID NOT HOLD A CHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375092 ↗
• MalfunctionAug 31, 2022Battery Problem; Battery Problem

  THE FREEDOM ONBOARD BATTERY WAS NOT SUPPORTING A PATIENT AT THE TIME OF THE EVENT. THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT THE FREEDOM ONBOARD BATTERY DID NOT CHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15332324 ↗
• MalfunctionJun 30, 2022Battery Problem; Battery Problem

  THE FREEDOM ONBOARD BATTERY WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM ONBOARD BATTERY DID NOT WORK/CHARGE TO ITS FULLEST CAPACITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877779 ↗
• MalfunctionJan 10, 2022Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available

  THE REPORTED ISSUES INVOLVE THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER TWO SEPARATE MEDICAL DEVICE REPORTS: (1) FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2022-00001 AND (2) FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2022-00002). THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE PATIENT WAS AT HOME WHEN THE FREEDOM DRIVER STARTED OVERHEAT AND EXHIBITED AN ALARM. THE PATIENT ALSO REPORTED THAT HE EXCHANGED THE FREEDOM DRIVER ONBOARD BATTERIES AND THE DRIVER STOPPED ALARMING. THE PATIENT PUT THE FREEDOM ONBOARD BATTERIES, THAT WERE IN THE DRIVER, INTO THE BATTERY CHARGER AND REPORTED THEY WOULD NOT FULLY CHARGE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214910 ↗
• MalfunctionJan 10, 2022Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available

  THE REPORTED ISSUES INVOLVE THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER TWO SEPARATE MEDICAL DEVICE REPORTS: (1) FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2022-00001 AND (2) FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2022-00002). THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE PATIENT WAS AT HOME WHEN THE FREEDOM DRIVER STARTED OVERHEAT AND EXHIBITED AN ALARM. THE PATIENT ALSO REPORTED THAT HE EXCHANGED THE FREEDOM DRIVER ONBOARD BATTERIES AND THE DRIVER STOPPED ALARMING. THE PATIENT PUT THE FREEDOM ONBOARD BATTERIES, THAT WERE IN THE DRIVER, INTO THE BATTERY CHARGER AND REPORTED THEY WOULD NOT FULLY CHARGE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214757 ↗
• MalfunctionJan 10, 2022Battery Problem; Battery Problem

  THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE PATIENT'S FREEDOM ONBOARD BATTERY WAS NOT HOLDING A CHARGE FOR AS LONG AS THE PATIENT EXPECTED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13204995 ↗
• MalfunctionJan 10, 2022Battery Problem; Battery Problem

  THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE PATIENT'S FREEDOM ONBOARD BATTERY WAS NOT HOLDING A CHARGE FOR AS LONG AS THE PATIENT EXPECTED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13204988 ↗
• MalfunctionNov 8, 2021Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available

  THE FREEDOM ONBOARD BATTERY WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT ONCE THE FREEDOM ONBOARD BATTERY WAS INSERTED INTO A FREEDOM DRIVER, THE DRIVER ANNUNCIATED AN ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775521 ↗
• MalfunctionSep 3, 2021Battery Problem; No Apparent Adverse Event; Battery Problem; No Apparent Adverse Event

  THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT PATIENT'S FREEDOM ONBOARD BATTERY DISCHARGED IMMEDIATELY AS SOON AS IT WAS INSERTED INTO THE FREEDOM DRIVER AFTER A COMPLETE CHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422262 ↗
• MalfunctionSep 3, 2021Battery Problem; Battery Problem

  THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT PATIENT'S FREEDOM ONBOARD BATTERY DISCHARGED IMMEDIATELY AS SOON AS IT WAS INSERTED INTO THE FREEDOM DRIVER AFTER A COMPLETE CHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422255 ↗
• MalfunctionAug 16, 2021Battery Problem; No Apparent Adverse Event; Battery Problem; No Apparent Adverse Event

  THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE PATIENT DROVE TO THE HOSPITAL FOR CLINIC VISIT AND WHILE ON WALL POWER THE FREEDOM DRIVER GAVE A LOW BATTERY ALARM. THE FREEDOM ONBOARD BATTERY WAS EXCHANGED AND THE ALARM RESOLVED. WHEN THE BATTERY WAS TESTED OUTSIDE OF THE DRIVER IT SHOWED NO CHARGE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329109 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030011. One submission often covers many models, so check the product and lot details in each record.

• Z-0126-2024 · Aug 1, 2023 · Completed
  SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
• Z-1022-2023 · Nov 2, 2022 · Open, Classified
  SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
• Z-0659-2017 · Oct 21, 2016 · Terminated
  5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
• Z-2731-2015 · Aug 6, 2015 · Terminated
  Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Hear
• Z-0620-2013 · Dec 5, 2012 · Terminated
  Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Sys