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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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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