Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Recalled by SynCardia Systems Inc. Due to The Main Printed Circuit Board Assembly (PCBA) of...
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
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Quantity: 5
Why Was This Recalled?
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.
Where Was This Sold?
US distribution to Virginia and Arizona.
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