SynCardia Companion Hospital Cart 397003-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00858000003138), received between Jun 21, 2022 and Aug 7, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PER HOSPITAL STAFF, THE HOSPITAL CART SCREEN TURNED PINK, WHEN BOTTOM LEFT CORNER OF THE SCREEN WAS BUMPED IT WOULD FLASH AND GLITCH. TOUCH SCREEN WAS NOT WORKING. NO ADVERSE IMPACT TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22743913 ↗
• MalfunctionJun 18, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THE COMPANION HOSPITAL CART DISPLAY SCREEN HAD A PIXILATED MAGENTA HUE, AND THAT THE FUNCTIONALITY OF THE DRIVER WAS NOT OTHERWISE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564040 ↗
• MalfunctionMay 3, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PER HOSPITAL STAFF, TOUCH SCREEN ON THE HOSPITAL CART DISPLAY DOES NOT RESPOND APPROPRIATELY. MULTIPLE ATTEMPTS AT CALIBRATING THE SCREEN WERE UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236900 ↗
• MalfunctionFeb 29, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PER HOSPITAL STAFF, THE HOSPITAL CART SCREEN WAS BLACK WHEN THE COMPANION 2 DRIVER WAS CONNECTED. THE TOUCH SCREEN STILL FUNCTIONED BUT THE SCREEN DID NOT LIGHT UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18812823 ↗
• MalfunctionOct 9, 2023No Display/Image; Appropriate Device Problem Term/Code Not Available; No Display/Image; Appropriate Device Problem Term/Code Not Available

  MONITOR/SCREEN OF HOSPITAL CART IS BLANK. C2 DRIVER SCREEN DOES NOT PROJECT TO HOSPITAL CART SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17901725 ↗
• MalfunctionMay 4, 2023Power Problem; Power Problem

  THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THE HOSPITAL CART SWITCHED TO BATTERY POWER WHILE CONNECTED TO AC POWER. THE POWER CABLE WAS REPLACED BUT THE ISSUE PERSISTED WITH THE CART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872953 ↗
• MalfunctionJan 31, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER, A CERTIFIED SYNCARDIA HOSPITAL, REPORTED THAT THERE WAS DIFFICULTY IN GETTING TOUCH SCREEN TO RECOGNIZE TOUCH, THAT THE SCREEN WOULD NOT CALIBRATE, AND WHEN DRIVER WAS REMOVED FROM THE HOSPITAL CART, THE DRIVER'S SCREEN FUNCTIONED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273443 ↗
• MalfunctionOct 13, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE COMPANION HOSPITAL CART WAS NOT SUPPORTING A PATIENT AT THE TIME OF THE EVENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE DISPLAY ON THE COMPANION HOSPITAL CART WAS "FROZEN", I.E., NOT RECOGNIZING TOUCH. THE HOSPITAL STAFF COULD NOT RECALIBRATE THE SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601296 ↗
• MalfunctionJun 21, 2022Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  DURING ROUTINE EVALUATION, A SYNCARDIA TECHNICIAN REPORTED THAT THE COMPANION HOSPITAL CART POWER CORD ICON DID NOT APPEAR ON THE SCREEN AS DESIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14757063 ↗

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