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SynCardia Systems Recalls
5 recalls on record · January 9, 2013 to November 1, 2023 · Medical Devices
Recalls by year
13
15
16
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 1, 2023Medical DevicesFDA
SynCardia Systems LLC recalls SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Hazard: Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
February 8, 2023Medical DevicesFDA
SynCardia Systems LLC recalls SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Hazard: Due to tears reported tears in the cannula due to wear and tear stress.
December 14, 2016Medical DevicesFDA
SynCardia Systems Inc. recalls 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-00
Hazard: 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.
September 23, 2015Medical DevicesFDA
SynCardia Systems Inc. recalls Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers
Hazard: 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.
January 9, 2013Medical DevicesFDA
SynCardia Systems Inc. recalls Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2
Hazard: 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.