SynCardia Companion Rechargeable LI-ION Battery 293001-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00858000003077), received between Sep 8, 2017 and Feb 21, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2023Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER WAS PLUGGED IN RUNNING ON WALL POWER, AND THEN ALARMED "EXTERNAL BATTERY ERROR." THE CUSTOMER CHANGED THE BATTERY AND THERE WERE NO FURTHER ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414849 ↗
• MalfunctionJun 30, 2022Battery Problem; Battery Problem

  THE COMPANION EXTERNAL BATTERY WAS NOT SUPPORTING A PATIENT AT THE TIME OF THE EVENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION EXTERNAL BATTERY ONLY CHARGED TO 60% OF ITS CAPACITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877482 ↗
• MalfunctionJun 28, 2022Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem

  THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT WHEN THE COMPANION EXTERNAL BATTERY WAS INSTALLED IN THE COMPANION 2 DRIVER, THERE WAS AN ERROR SYMBOL OVER THE BATTERY ICON ON MAIN DRIVER DISPLAY. THE CUSTOMER ALSO REPORTED THE COMPANION EXTERNAL BATTERY GAUGE LIGHTS DID NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14847090 ↗
• MalfunctionMay 17, 2021Power Problem; Appropriate Device Problem Term/Code Not Available; Power Problem; Appropriate Device Problem Term/Code Not Available

  THE COMPANION EXTERNAL BATTERY WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT COMPANION EXTERNAL BATTERY DID NOT CHARGE AFTER ONE WEEK IN THE COMPANION 2 DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832369 ↗
• MalfunctionJun 11, 2018Failure to Charge; Disconnection; Battery Problem; Battery Problem

  THIS COMPANION EXTERNAL BATTERY WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER WAS DISCONNECTED FROM WALL POWER WHILE IN THE HOSPITAL LABORATORY. THE CUSTOMER ALSO REPORTED THAT THE COMPANION 2 DRIVER WAS RECONNECTED TO WALL POWER AND AFTER APPROXIMATELY ONE WEEK, THE COMPANION EXTERNAL BATTERY DID NOT CHARGE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7586817 ↗
• MalfunctionJun 11, 2018Premature Discharge of Battery; Aborted Charge; Premature Discharge of Battery

  THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION EXTERNAL BATTERY COULD ONLY BE USED IN THE COMPANION 2 DRIVER FOR 20 MINUTES BEFORE LOSING ITS CHARGE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7586807 ↗
• MalfunctionJun 11, 2018Failure to Charge; Battery Problem

  THIS COMPANION EXTERNAL BATTERY WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER WAS DISCONNECTED FROM WALL POWER WHILE IN THE HOSPITAL LABORATORY. THE CUSTOMER ALSO REPORTED THAT THE COMPANION 2 DRIVER WAS RECONNECTED TO WALL POWER AND AFTER APPROXIMATELY ONE WEEK, THE COMPANION EXTERNAL BATTERY DID NOT CHARGE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7586806 ↗
• MalfunctionSep 8, 2017Failure to Charge; Battery Problem

  THIS COMPANION EXTERNAL BATTERY WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION EXTERNAL BATTERY WOULD NOT CHARGE AFTER 24 HOURS IN A COMPANION 2 DRIVER.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6852803 ↗

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