SynCardia Companion Driver Caddy 397001-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00858000003145), received between Jun 23, 2023 and Dec 27, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2023Break; Break

  PERFUSIONIST REPORTED TO CLINICAL ON SITE THAT EXTRA CADDY THEY HAVE HAS A BROKEN LATCH - WILL NOT PUSH DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400829 ↗
• MalfunctionJul 27, 2023Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER, A (B)(6) HOSPITAL, REPORTED THAT A C2 DRIVER WAS STUCK IN THE CADDY - THEY CAN'T PRESS IN THE LOCK BUTTON TO REMOVE THE DRIVER. STATES DRIVER IS SEATED PROPERLY IN THE CADDY GROOVE. EMAIL LATER RECEIVED THAT BIOMED WAS FINALLY ABLE TO REMOVE THE DRIVER FROM THE CADDY, BUT THEY ARE REQUESTING TO SEND IT BACK TO BE CHECKED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17408390 ↗
• MalfunctionJun 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING ROUTINE EVALUATION, A SYNCARDIA TECHNICIAN REPORTED THE COMPANION CADDY FAILED INCOMING FUNCTIONAL TESTING DUE TO NO VOLTAGE OUTPUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17191625 ↗

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