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.
- 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…
- Category
- Medical Device
- Distribution
- Distributed nationwide