SynCardia temporary Total Artificial Heart System 500101-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 215 adverse event reports that list this exact device (DI 00858000003008), received between Jan 31, 2017 and Aug 19, 2026 — classified as 141 deaths, 21 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (17 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 215 reports, in the reporter's own words as published by the FDA.

• DeathAug 19, 2026Adverse Event Without Identified Device or Use Problem

  Hospital staff reported patient death due to multisystem organ failure. Hospital staff confirmed death was unrelated to the device. Device not available for evaluation as no explant or autopsy performed.

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 50328984 ↗
• DeathAug 19, 2026Adverse Event Without Identified Device or Use Problem

  Per distributor, patient died due to intracranial hemorrhage. The device was stated to not have contributed or caused the patient death.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50326814 ↗
• DeathAug 18, 2026Adverse Event Without Identified Device or Use Problem

  Received Outcome Form for the patient with TAH SN#(b)(6) who died due to sepsis. Hospital staff confirmed patient death was unrelated to device.

  Patient problems: Sepsis

  MAUDE report 50312254 ↗
• DeathAug 18, 2026Adverse Event Without Identified Device or Use Problem

  Per hospital staff, reported patient death due to multi-organ system failure. No autopsy or explant performed. The device was reported by medical staff onsite to not have caused or contributed to to the patient death.

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 50312188 ↗
• DeathAug 18, 2026Adverse Event Without Identified Device or Use Problem

  Hospital reported patient death due to multi-organ system failure. No autopsy or explant performed. Medical staff confirmed that the device did not cause or contribute to the patient death.

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 50312062 ↗
• DeathAug 18, 2026Adverse Event Without Identified Device or Use Problem

  Per hospital staff, patient was diagnosed with sepsis and the determination was made to remove the patient from STAH support by the patient and their family. The patient was removed from support in hospital. The device was stated to not have contributed or caused the patient death.

  Patient problems: Sepsis

  MAUDE report 50311905 ↗
• DeathMay 28, 2026Adverse Event Without Identified Device or Use Problem

  HOSPITAL STAFF REPORTED DEATH OF PATIENT FOLLOWING A CATASTROPHIC RIGHT INTRAPARENCHYMAL HEMORRHAGE WITH BRAIN HERNIATION. NO DEVICE MALFUNCTION OCCURRED AND PATIENT DEATH WAS REPORTED TO BE UNRELATED TO THE DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25325442 ↗
• MalfunctionMar 17, 2026Material Integrity Problem

  PER HOSPITAL STAFF, PATIENT'S FEMALE CPC CONNECTOR FOUND WITH DISPLACED SPRING DUE TO THE ZIP TIE PLACED ON CONNECTOR. THIS ISSUE WAS FOUND DURING IMPLEMENTATION OF NEW CPC CONNECTOR COVERS, A MITIGATION TO RESOLVE DISPLACED SPRINGS AND OBSOLESCING THE USE OF ZIP TIES. THE PATIENT HAD TO BE PUT BACK ON THE COMPANION 2 DRIVER DURING REPLACEMENT. THE COMPONENT WAS SUCCESSFULLY REPLACED. NO IMPACT TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618408 ↗
• MalfunctionFeb 18, 2026Break

  PER DISTRIBUTOR, THE PATIENT'S CANNULA BROKE. THE PATIENT TEMPORARILY TAPED IT AT HOME, AND THEN THE HOSPITAL STAFF FIXED IT BY CUTTING DAMAGED PART. NOW RED PART OF CANNULA IS SHORTER THEN BLUE PART. NO ADVERSE IMPACT TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381577 ↗
• MalfunctionFeb 17, 2026Break

  PER DISTRIBUTOR, THE PATIENT'S CANNULA BROKE FOR THE SECOND TIME IN TWO YEARS. THE PATIENT TEMPORARILY TAPED IT AT HOME, AND THEN IN THE HOSPITAL THEY BARELY MANAGED TO FIX THE CANNULA BY INSERTING A PIECE OF DRIVELINE CPC CONNECTOR IN PLACE TO HOLD THE CANNULA TOGETHER. PATIENT WAS HOSPITALIZED, SAE IS COVERED UNDER (B)(4). THIS COMPLAINT COVERS EXCLUSIVELY THE POTENTIAL MATERIAL DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370700 ↗
• MalfunctionDec 23, 2025Crack; Material Integrity Problem; Crack; Material Integrity Problem

  PER DISTRIBUTOR, THE PATIENT'S CANNULA BROKE FOR THE SECOND TIME. THE FIRST CANNULA TEAR OCCURRED ON (B)(6) 2023, TWO YEARS PRIOR. ON THIS OCCASION, THE PATIENT TEMPORARILY TAPED IT AT HOME, AND THEN IN THE HOSPITAL THEY BARELY MANAGED TO FIX THE CANNULA BY INSERTING A PIECE OF DRIVELINE CPC CONNECTOR. PATIENT IS BEING HELD IN THE HOSPITAL UNTIL A DECISION IS MADE ON HOW TO FIX OR REPLACE THE VENTRICLE. NO SERIOUS INJURY TO THE PATIENT OCCURRED, HOWEVER, A PROLONGED HOSPITAL STAY IS EXPECTED AS THE INTERVENTION REQUIRED IS NOT READILY ACCESSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885111 ↗
• MalfunctionSep 8, 2025Material Integrity Problem; Material Integrity Problem

  PER HOSPITAL STAFF, THE SPRING INSIDE THE CPC CONNECTOR ON THE RED CANNULA WAS DISLODGED AND HORIZONTAL INSTEAD OF VERTICAL, PREVENTING THE SILVER BUTTON TO BE PRESSED UPON CHANGING THE PATIENT FROM THE FREEDOM DRIVER TO THE C2 DRIVER. CPC CONNECTOR HAD TO BE REPLACED. NO ADVERSE IMPACT TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994806 ↗
• MalfunctionSep 8, 2025Material Puncture/Hole; Material Puncture/Hole

  PER HOSPITAL STAFF, DEMARCATION NOTED ON THE LEFT CANNULA NEAR THE CPC CONNECTOR. NO CRACK OR AIR LEAKS NOTED. REINFORCED WITH RESCUE TAPE. NO ADVERSE IMPACT TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994782 ↗
• MalfunctionAug 20, 2025Material Puncture/Hole; Material Puncture/Hole

  PER THE HOSPITAL STAFF, PATIENT CALLED MCS COORDINATOR REPORTING NOT FEELING WELL, COULD HEAR AND FEEL AIR HISSING FROM RED CANNULA OF TAH. PATIENTS WIFE SUCCESSFULLY TAPED THE RED CANNULA. PATIENT BROUGHT INTO CLINIC, CRACK ON RED CANNULA END OF CPC CONNECTOR. CANNULA WAS CUT PROXIMAL TO CRACK AND PATIENT CHANGED ONTO NEW FREEDOM DRIVER. IN ORDER TO FACILITATE AN EASIER TRANSITION TO THE REPAIRED CANNULA, THE HOSPITAL STAFF DETERMINED SWITCHING THE PATIENT TO A BACKUP DRIVER WOULD BE QUICKER AND EASIER. THE CUT SEGMENT OF CANNULA THAT WAS REMOVED DURING THE REPAIR WAS RETURNED WITH THE INITIAL FREEDOM DRIVER, HOWEVER, NO COMPLAINT WAS MADE AGAINST THE DRIVER FOR THIS COMPLAINT. THE FREEDOM DRIVER HAD FUNCTIONED AS INTENDED. NO ISSUES WITH THE CPC CONNECTOR WERE REPORTED, THE CHANGEOUT WENT SMOOTHLY WITHOUT ANY ADVERSE IMPACT TO PATIENT. CRACK WAS REPORTED TO BE ON THE PATIENT END OF THE CANNULA. NO ADVERSE IMPACT TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853846 ↗
• MalfunctionJul 1, 2025Leak/Splash; Insufficient Device Problem Information; Leak/Splash; Insufficient Device Problem Information

  PER THE IMPLANTING HOSPITAL STAFF, THE PATIENT WAS INITIALLY IMPLANTED WITH RIGHT AND LEFT VENTRICLES FROM TAH-T KIT (SN: (B)(6)), DEVICE WAS TURNED ON, BYPASS TURNED OFF. SURGEON NOTED BLOOD "LEAKING" FROM RIGHT VENTRICLE. BLOOD NOTED TO BE COMING OUT OF RIGHT VENTRICLE NEAR THE INFLOW CONNECTOR/VALVE. PATIENT PLACED BACK ON BYPASS, TAH TURNED OFF. RIGHT VENTRICLE (ID (B)(6)) REMOVED FROM PATIENT. NEW IMPLANT KIT OBTAINED (SN (B)(6)) AND NEW RIGHT VENTRICLE ( ID: (B)(6)) IMPLANTED. PATIENT WAS ULTIMATELY SUCCESSFULLY IMPLANTED AFTER BEING PLACED BACK ON BYPASS, THEN REPLACEMENT VENTRICLE WAS IMPLANTED AND PATIENT TAKEN OFF BYPASS, FULLY SUPPORTED ON THE TAH. NO OTHER ADVERSE IMPACT TO PATIENT WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379036 ↗
• DeathFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED DEATH OF PATIENT DUE TO MULTI-SYSTEM ORGAN FAILURE. PATIENT'S FAMILY DECIDED TO WITHDRAW CARE DUE TO HEALTH STATUS. NO AUTOPSY WAS PERFORMED, THE DEVICE WAS NOT EXPLANTED, AND HOSPITAL STAFF REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH.

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 21428428 ↗
• DeathJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER HOSPITAL STAFF, REPORTED DEATH OF PATIENT FROM MULTI-SYSTEM ORGAN FAILURE AFTER 742 DAYS ON SUPPORT. THE OUTCOME FORM INDICATES THERE WAS NO AUTOPSY, THE DEVICE WAS NOT EXPLANTED, AND THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH.

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 21231590 ↗
• MalfunctionJan 17, 2024Material Puncture/Hole; Material Puncture/Hole

  PER HOSPITAL STAFF, PATIENT'S BLUE CANNULA HAD A CRACK BY THE CPC CONNECTOR. THE CPC CONNECTOR WAS CHANGED OUT BY REMOVING PART OF THE CANNULA WITH A WIRE CUTTER. PATIENT REPORTEDLY TOLERATED THE REPAIR WELL. RESCUE TAPE WAS PLACED AROUND THE CANNULAS POST REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18529553 ↗
• MalfunctionOct 30, 2023Material Separation; Appropriate Device Problem Term/Code Not Available; Material Separation; Appropriate Device Problem Term/Code Not Available

  CLINICAL SPEC RECEIVED A CALL FROM UAB MCS COORDINATORS (B)(4) REGARDING ACCIDENTAL DISCONNECTION ON LEFT SIDE CANNULA RESULTING IN A LOW PRESSURE ALARM BUT NO DROP IN CARDIAC OUTPUT. THEY IMMEDIATELY RECONNECTED THE DRIVELINE AND REPLACED THE ZIP TIES. REPORTED THEY HAD TO CUT OFF THE OLD ZIP TIE AND IT APPEARED TO HAVE THE GROOVES WORN OFF. THEY KEPT THAT ZIP TIE AND WILL BE RETURNING IT. PATIENT WAS STARTLED, BUT AWAKE AND STABLE DURING EVENT. SPOKE WITH MARIA AFTER AND REQUESTED PICTURES WHICH ARE ATTACHED. APPEARS ZIP TIES MAY NOT HAVE BEEN PLACED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035669 ↗
• MalfunctionMay 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR REPORTED THE THREE-WAY STOPCOCK CANNOT BE CONNECTED WITH THE TESTER BECAUSE THE HOLE ON THE TESTER IS TOO SMALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005584 ↗
• MalfunctionMay 16, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT THE PATIENT OBSERVED AIR LEAKING FROM A CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943189 ↗
• MalfunctionApr 28, 2023Contamination; Material Integrity Problem; Contamination; Material Integrity Problem

  THE CUSTOMER, A (B)(6)HOSPITAL, REPORTED THAT A HAIR WAS FOUND WITHIN THE STERILE PACKAGING OF ONE OF THE 25MM PRESSURE TEST PLUGS. THE ITEM AND PACKAGING WERE DISPOSED OF, AND THE SURGICAL SPARES KIT WAS OPENED TO OBTAIN ANOTHER 25MM PRESSURE TEST PLUG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16835107 ↗
• MalfunctionApr 14, 2023Crack; Material Integrity Problem; Crack; Material Integrity Problem

  THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT THE PATIENT HAD A TEAR ON ONE CANNULA LINE. THE CANNULA WAS REVIEWED BY CLINICAL SUPPORT TO BE A SINGLE THICKNESS TEAR, AND THERE WAS NO AIR LEAKING FROM THE CANNULA. CLINICAL SUPPORT SENT SECTIONS OF CANNULA TO THE DISTRIBUTOR FOR THEM TO EVALUATE A POSSIBLE REPLACEMENT OF THE TORN SECTION OF CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743357 ↗
• MalfunctionFeb 28, 2023Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem

  THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED HEARING AIR ESCAPING FROM LEFT CANNULA WHEN PATIENT REPOSITIONED. UPON VISUAL EXAMINATION WITH SYNCARDIA CLINICAL SUPPORT, IT WAS FOUND THAT BOTH CANNULAS WERE PARTIALLY TAPED WITH PURPLE SILICON TAPE. WHEN THE TAPE WAS MOVED, AIR WAS CLEARLY HEARD COMING FROM LEFT CANNULA NEAR THE CONNECTOR/JUNCTION WHERE CANNULAS WERE PREVIOUSLY REPAIRED/REPLACED. THE PATIENT WAS UNABLE TO PROVIDE ANY DETAILS AS TO HOW LONG THIS HAD BEEN OCCURRING. THE ICU RN APPLIED CLEAR SILICON TAPE TO REINFORCE BOTH CANNULAS AROUND THE UPPER CONNECTORS, AND NO AIR WAS HEARD AND NO ALARMS WERE NOTED WITH PATIENT MOVEMENT AFTER THIS APPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452366 ↗
• DeathSep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE PATIENT WAS FOUND UNRESPONSIVE, NOT BREATHING WITH PUPILS FIXED AND DILATED, AT HIS HOME IN (B)(6). THE FREEDOM DRIVER SUPPORTING THE PATIENT WAS ALARMING AND THE DAUGHTER EXCHANGED TO A BACK-UP FREEDOM DRIVER. THE CUSTOMER AND EMS WERE ON PHONE TOGETHER AND CONFIRMED THAT THE FREEDOM DRIVER WAS NOT ALARMING AND THERE WERE NO AIR LEAKS IN THE CANNULAE/DRIVELINES. EMS INTUBATED THE PATIENT AND WAS INSTRUCTED TO BRING PATIENT TO (B)(6) HOSPITAL AS IT WAS CLOSER THAN HIS CARE FACILITY (B)(6). EN ROUTE THE FREEDOM DRIVER BEGAN TO ALARM AND ONCE AT (B)(6), THE PATIENT WAS SWITCHED TO ANOTHER BACKUP FREEDOM DRIVER. THE CUSTOMER ALSO REPORTED THAT WHILE AT (B)(6), A HEAD CT SCAN WAS PERFORMED AND LOSS OF GREY-WHITE MATTER CONSISTENT WITH ANOXIC BRAIN INJURY- NO BLEEDING WAS FOUND. THE ATTENDING PHYSICIAN MADE AN INITIAL DIAGNOSIS OF ANOXIC BRAIN INJURY. THE PATIENT WAS TRANSFERRED (B)(6) VIA AIR AND THE CT FILMS WERE REVIEWED AND CUSTOMER AGREED WITH THE DIAGNOSIS MADE AT (B)(6). THE PATIENT WAS UNSTABLE OVERNIGHT REQUIRING MULTIPLE PRESSORS, NO SEDATION, NON-RESPONSIVE NOT BREATHING OVER VENTILATOR. PATIENT WAS SWITCHED TO A

  Patient problems: Brain Injury

  MAUDE report 15382436 ↗

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