SynCardia 50cc TAH-t, Clinical 570500-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00858000003053), received between May 28, 2020 and Aug 19, 2026 — classified as 5 deaths.

1 FDA recall record name this device's identifier.

4 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.

Recalls naming this device

1. Aug 1, 2023Class IICompleted

   Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.

   Z-0126-2024 · Root cause: Other · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

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

  Per distributor, patient died due to multisystem organ failure. Death reported not caused by STAH device. No autopsy was performed.

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 50327861 ↗
• DeathNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2021. THE CUSTOMER REPORTED THE CAUSE OF DEATH AS MULTI-ORGAN SYSTEM FAILURE AND THAT THE TAH-T WAS NOT EXPLANTED AND NO AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 12760530 ↗
• DeathMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2021. THE CUSTOMER REPORTED THE CAUSE OF DEATH AS MULTI-ORGAN SYSTEM FAILURE AND INDICATED THAT THE TAH-T DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. THE TAH-T WAS NOT EXPLANTED AND NO AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 11832382 ↗
• DeathDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2020. THE CUSTOMER REPORTED THE CAUSE OF DEATH AS SEPSIS AND OTHER: PULMONARY BLEEDING. CAUSES OR CONTRIBUTING FACTORS FOR THE DEATH WERE LISTED AS PERSISTENT INTRAPULMONARY BLEEDING AFTER TRACHEOTOMY, BACTERIAL AND FUNGAL SEPSIS, AND HEMOLYSIS WITH HIGH LEVELS OF BILIRUBIN. THE TAH WAS NOT EXPLANTED AND NOT AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Hemolysis; Hemorrhage/Blood Loss/Bleeding; Sepsis

  MAUDE report 11032624 ↗
• DeathMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT THE PATIENT DIED ON (B)(6) 2020. THE CUSTOMER REPORTED THE CAUSE OF DEATH AS MULTI-ORGAN SYSTEM FAILURE AND SEPSIS. THE CUSTOMER ALSO REPORTED THAT THE TAH WAS NOT EXPLANTED AND NO AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Death; Multiple Organ Dysfunction Syndrome; Sepsis

  MAUDE report 10096944 ↗

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-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