SynCardia Systems

5 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices, Infusion Pumps

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

Class I - Dangerous

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

Aug 1, 2023 Other Medical Devices View Details →

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

Class I - Dangerous

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

Nov 2, 2022 Other Medical Devices Nationwide View Details →

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

Class I - Dangerous

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.

Oct 21, 2016 Infusion Pumps View Details →

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.

Class I - Dangerous

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.

Aug 6, 2015 Infusion Pumps Nationwide View Details →

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 Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

Class I - Dangerous

Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning.

Dec 5, 2012 Infusion Pumps Nationwide View Details →