SynCardia Freedom Driver System Recalled for Potential Silent Failure
SynCardia Systems Inc. is recalling five Freedom Driver Systems because the main circuit board may fail silently, causing 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 aligns with the rubric criterion for known fatalities or critical life-threatening hazards.
Plain-English summary
SynCardia Systems Inc. is recalling five units of the 5000 Series Freedom Drivers, part of the Freedom Driver System for Temporary Total Artificial Heart (TAH-t). The specific part number for the recalled items is 595000-001.
The recall is due to a defect in the Main Printed Circuit Board Assembly (PCBA). This component may fail without providing any visual or audible alarms. Such a failure would cause the Freedom Driver to stop functioning, resulting in the loss of life-sustaining function for the patient.
The affected units were distributed in the United States to Virginia and Arizona. The specific serial numbers involved are 5002, 5005, 5008, 5009, and 5010. Users should contact SynCardia Systems Inc. for further instructions on how to address this defect.
The recalled product
- Product
- 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
- Manufacturer
- SynCardia Systems Inc.
- Category
- Medical Device — Cardiovascular
- Affected units
- 5
Distribution
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