SynCardia Recalls Freedom Drivers for Potential Drive Mechanism Failure
SynCardia Systems is recalling Freedom Drivers because a component may fail, causing the drive mechanism to stop pumping and resulting in the loss of life-sustaining function.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that the defect results in the 'loss of life-sustaining function,' which constitutes a known fatality or critical injury risk, meeting the criteria for a Critical (Score 5) severity rating.
Plain-English summary
SynCardia Systems, Inc. is recalling Freedom Drivers, which are components of the SynCardia temporary Total Artificial Heart (TAH-t) System. The recall is due to a specific component of the drive mechanism that may fail.
If this component fails, it may cause the drive mechanism to stop pumping. This failure results in the loss of life-sustaining function for the patient. The Freedom Drivers are indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure and are intended for use in and out of the hospital.
The recall involves 56 drivers, of which 21 are currently in use on patients. The affected units were distributed worldwide, including in the United States (AR, NC, CA, OH, PA, TX, MI, and VA) and in Germany, Turkey, and France. Patients and healthcare providers should contact SynCardia Systems for further instructions regarding the recall and replacement of these devices.
The recalled product
- Product
- 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 immine
- Manufacturer
- SynCardia Systems Inc.
- Category
- Medical Device — Cardiovascular
Distribution
Related recalls
Same manufacturer · SynCardia Systems Inc.
See all →- CriticalSynCardia Freedom Driver System Recalled for Potential Silent Failure
FDA (Devices) · 2016-12-14
- SevereSynCardia Recalls Companion External Batteries Due to Thermal Event Risk
FDA (Devices) · 2013-01-09
Same hazard · mechanical failure
See all →- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28