Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF Recalled by SynCardia Systems Inc. Due to SynCardia Systems, Inc. is recalling Freedom Drivers due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SynCardia Systems Inc. directly.
Affected Products
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.
Quantity: 56 drivers (21 currently in use on patients)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SynCardia Systems Inc.
SynCardia Systems Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report