# P030011: Syncardia Temporary Cardio West Total Artificial Heart (Tah-T)

- Pathway: PMA
- Applicant: Syncardia Systems, LLC
- Decided: Oct 15, 2004 after 553 days
- Product code: LOZ (Artificial Heart)
- Device class: 3
- Recalls of this device: 5 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Aug 1, 2023 · Class II · Z-0126-2024: Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
- Nov 2, 2022 · Class II · Z-1022-2023: Due to tears reported tears in the cannula due to wear and tear stress.
- Oct 21, 2016 · Class I · Z-0659-2017: 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
- Aug 6, 2015 · Class I · Z-2731-2015: 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
- Dec 5, 2012 · Class II · Z-0620-2013: 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 m

Source page: https://510kreport.com/device/P030011
Methodology: https://510kreport.com/methodology