SynCardia Companion 2 Driver 397002-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 414 adverse event reports that list this exact device (DI 00858000003107), received between Apr 8, 2016 and Sep 22, 2026 — classified as 2 deaths, 15 injuries, 397 malfunctions.

The most frequently reported specific device problem is “Audible Prompt/Feedback Problem” (177 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 414 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Audible Prompt/Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862834 ↗
• MalfunctionSep 16, 2026Battery Problem

  Per hospital staff, the Companion 2 Driver did not recognize external batteries at all. They tried cleaning the driver and tried multiple batteries that worked in other drivers without issue. Driver failed System Check prior to being placed on a patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791253 ↗
• MalfunctionSep 16, 2026Audible Prompt/Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790150 ↗
• MalfunctionSep 16, 2026Audible Prompt/Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790149 ↗
• MalfunctionSep 16, 2026Insufficient Device Problem Information

  Per hospital staff, C2 Driver did not pass system check test prior to patient use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790140 ↗
• MalfunctionDec 22, 2025Charging Problem; Charging Problem

  PER HOSPITAL STAFF, COMPANION 2 DRIVER 10194A DELIVERED FOR NEW IMPLANT AND DESPITE BEING PLACED IN CADDY AND PLUGGED INTO WALL POWER FOR TWO SUBSEQUENT DAYS, THE INTERNAL BACKUP BATTERY WOULD NOT CHARGE. C2 DRIVER WAS NOT ABLE TO BE USED FOR IMPLANT AND REPLACEMENT C2 REQUIRED. DEVICE NOT YET IN PATIENT USE AT TIME OF COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872251 ↗
• MalfunctionSep 17, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PER HOSPITAL STAFF, TOUCH SCREEN ON COMPANION 2 DRIVER S/N (B)(6) WILL NOT CHANGE BEAT RATE WHILE IN ICU MODE. SCREEN CALIBRATED MULTIPLE TIMES AND BEAT RATE IS NOT ABLE TO BE ADJUSTED WHILE IN ICU MODE. DRIVER WAS SWAPPED OUT FOR ANOTHER DRIVER WITHOUT ANY ADVERSE IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23079334 ↗
• MalfunctionAug 4, 2025Battery Problem; Battery Problem

  PER MANUFACTURER QUALITY TECHNICIAN, COMPANION 2 DRIVER WAS CONNECTED FOR FOR FIVE DAYS TO POWER TO LET EMERGENCY BATTERY TO CHARGE FOR ROUTINE SERVICE. DRIVER FAILED STEP OP 070 ON SERVICE SHOP ORDER DUE TO OBSERVED EMERGENCY BATTERY ERROR. INCOMING INSPECTION COULD NOT CONTINUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709982 ↗
• MalfunctionJun 3, 2025Noise, Audible; Audible Prompt/Feedback Problem; Noise, Audible; Audible Prompt/Feedback Problem

  PERFUSIONIST NOTIFIED CLINICAL TEAM ABOUT THE EXTERNAL AIR NOT LIGHTING UP AND THE COMPRESSOR SOUNDING DIFFERENT. ON (B)(6) 2025, THE DECISION WAS MADE TO SWITCH OUT THE DRIVER WHEN BACK IN THE OPERATING ROOM TO CLOSE THE CHEST. NO ADVERSE IMPACT TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135115 ↗
• MalfunctionFeb 18, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  PER DISTRIBUTOR, AFTER SYSTEM CHECKOUT, DEVICE DISPLAYED SINGLE COMPRESSOR MALFUNCTION MESSAGE. DEVICE WAS NOT IN PATIENT USE AT TIME OF COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407031 ↗
• MalfunctionFeb 18, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  PER DISTRIBUTOR, AFTER SYSTEM CHECKOUT, DEVICE DISPLAYED SINGLE COMPRESSOR MALFUNCTION MESSAGE. DEVICE WAS NOT IN PATIENT USE AT TIME OF COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21406896 ↗
• MalfunctionFeb 18, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  PER DISTRIBUTOR, AFTER SYSTEM CHECKOUT, DEVICE DISPLAYED SINGLE COMPRESSOR MALFUNCTION MESSAGE. DEVICE WAS NOT IN PATIENT USE AT TIME OF COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405329 ↗
• MalfunctionJan 24, 2025Output Problem; Audible Prompt/Feedback Problem; Output Problem; Audible Prompt/Feedback Problem

  WHILE SUPPORTING THE PATIENT THERE WERE PERIODIC "LEFT PRESSURE INCORRECT" NOTIFICATIONS ON THE ALARM NOTIFICATION AREA ON THE C2 DRIVER AND HOSPITAL CART. THE PATIENT WAS STABLE AND THE WAVEFORMS CONTINUED TO SHOW FULL EJECT AND PARTIAL FILL STATUS. PATIENT'S CARDIAC OUTPUT WAS NOT AFFECTED AND WAS COMPLETELY STABLE IN HIS PHYSIOLOGIC PARAMETERS. PATIENT WAS SWITCHED TO A FREEDOM DRIVER WITHOUT ANY REPORTED ADVERSE IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231602 ↗
• MalfunctionJan 8, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  C2 DRIVER SPONTANEOUSLY ALARMED SYSTEM MALFUNCTION WHILE SUPPORTING A PATIENT. VAC HAD BEEN AT <13> AND PERFUSIONIST DROPPED IT TO <8>; IMMEDIATE VAC INCORRECT AS WELL AS SYSTEM MALFUNCTION ALARM ANNUNCIATED. SYNCARDIA CLINICAL AFFAIRS STAFF TRIED TO RESET THE MACHINE AND WAS UNABLE TO CLEAR THE ALARM. PATIENT WAS SWITCHED TO BACKUP C2 DRIVER WITHOUT ANY REPORTED ADVERSE IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103721 ↗
• MalfunctionDec 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  C2 DRIVER TOUCH SCREEN WAS NOT WORKING APPROPRIATELY. WHEN SCREEN IS PRESSED IT DID NOT ALWAYS ACKNOWLEDGE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859708 ↗
• MalfunctionDec 5, 2024Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  SYSTEM MALFUNCTION ALARM ANNUNCIATED DURING IMPLANTATION OF PATIENT IN HOSPITAL OR. UPON INITIATING THE VACUUM TO AN OUT OF SPECIFICATION SETTING, SYNCARDIA CLINICAL AFFAIRS REPRESENTATIVE SUGGESTED THAT HOSPITAL STAFF INCREASE TO VACUUM SETTINGS TO AVOID AN ALARM ON THE C2 DRIVER. SYNCARDIA REP EXPLAINED THAT INITIATING VACUUM AT A LOWER SETTING, CAN SOMETIMES TRIGGER THIS ALARM AND THAT IT IS PREFERABLE TO BEGIN AT A HIGHER SETTING TO AVOID THIS ISSUE. WHEN THE SYSTEM MALFUNCTION ALARM WAS ACTIVE, LOW FILL VOLUMES (FV) ON BOTH THE LEFT AND RIGHT SIDES WERE OBSERVED. ALTHOUGH THE WAVEFORMS APPEARED NORMAL, THEY DID NOT CORRESPOND TO THE MEASURED FV OR CARDIAC OUTPUT (CO). AT THAT TIME, THE CENTRAL VENOUS PRESSURE (CVP) WAS ELEVATED. FOLLOWING THE TRANSITION TO THE BACKUP SYSTEM, THERE WAS A MARKED IMPROVEMENT. THE FILL VOLUMES STABILIZED, AND THE CO INCREASED WITHIN SPECIFICATIONS AND PATIENT'S CVP DECREASED TO WITHIN SPECIFICATIONS. NO FURTHER ALARMS OR SYSTEM ISSUES WERE OBSERVED AFTER THE SWITCH TO BACKUP DRIVER. NO ADVERSE IMPACT TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859590 ↗
• MalfunctionNov 13, 2024Battery Problem; Battery Problem

  PER HOSPITAL STAFF, C2 DRIVER NOT RECOGNIZING BATTERIES AS BEING INSERTED. ATTEMPTED TROUBLESHOOTING WITH DIFFERENT BATTERIES WITH NO CHANGE. DRIVER NOT IN PATIENT USE AT TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679167 ↗
• MalfunctionNov 13, 2024Battery Problem; Battery Problem

  PER HOSPITAL STAFF, COMPANION C2 DRIVER IS NOT RECOGNIZING THE EXTERNAL BATTERIES WHILE DOING THE CONSOLE CHECK-UP. STAFF CONFIRMED IT WAS NOT THE BATTERIES, JUST THE INITIAL DRIVER. DRIVER WAS NOT IN PATIENT USE AT TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679097 ↗
• MalfunctionOct 1, 2024Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  PER HOSPITAL STAFF, PATIENT ON COMPANION 2 DRIVER HAD AN ALARM FOR "LEFT INCORRECT PRESSURE READING". PATIENT WAS SWITCHED TO A BACKUP DRIVER WITHOUT ANY REPORTED ADVERSE IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348798 ↗
• MalfunctionAug 23, 2024Battery Problem; Audible Prompt/Feedback Problem; Battery Problem; Audible Prompt/Feedback Problem

  PER DISTRIBUTOR, AFTER SYSTEM CHECKOUT, DEVICE DISPLAYED MESSAGE, SINGLE COMPRESSOR MALFUNCTION. ALSO, INTERNAL BATTERY COULD NOT BE CHARGED. DEVICE NOT IN PATIENT USE AT TIME OF COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20050768 ↗
• MalfunctionAug 23, 2024Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  PER DISTRIBUTOR, AFTER SYSTEM CHECKOUT DEVICE DISPLAYED MESSAGE, VACUUM MALFUNCTION. DEVICE NOT IN PATIENT USE AT TIME OF COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049380 ↗
• MalfunctionAug 22, 2024Overheating of Device; Appropriate Device Problem Term/Code Not Available; Overheating of Device; Appropriate Device Problem Term/Code Not Available

  PER DISTRIBUTOR, DEVICE IS OVERHEATING AND FAN CONSTANTLY RUNS. DEVICE WAS ON THE PATIENT BUT THERE WAS NO REPORTED ADVERSE IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20044828 ↗
• MalfunctionAug 22, 2024Battery Problem; Battery Problem

  PER DISTRIBUTOR, FULLY CHARGED BATTERIES NOT RECOGNIZED BY THE DEVICE. DEVICE WAS NOT IN PATIENT USE AT TIME OF COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20044257 ↗
• MalfunctionAug 22, 2024Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  PER DISTRIBUTOR, AFTER SYSTEM CHECKOUT AND CONNECTING ON AN EXTERNAL AIR, DEVICE DISPLAYED MESSAGE, SINGLE COMPRESSOR MALFUNCTION. DEVICE NOT IN PATIENT USE AT TIME OF COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043589 ↗
• MalfunctionAug 22, 2024Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  ACCORDING TO DISTRIBUTOR, DURING SYSTEM CHECKOUT DEVICE DISPLAYED MESSAGE, SINGLE COMPRESSOR MALFUNCTION. DEVICE NOT IN PATIENT USE AT TIME OF COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043207 ↗

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