Artificial Heart

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2023-10-20CompletedOther

  SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

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

• 2023-01-27Open, ClassifiedDevice Design

  SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

  Due to tears reported tears in the cannula due to wear and tear stress.

• 2015-09-17TerminatedComponent design/selection

  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 Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.

  SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function.

• 2008-09-20TerminatedProcess control

  Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is intended to be implanted in the thoracic cavity and replaces operation and function of the native heart.

  Subassembly incorrectly aligned

• TerminatedProcess control

  5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001

  The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audible alarms, resulting in the loss of life-sustaining function.