SynCardia Systems Inc. recalls 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
- Recall date
- October 21, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0659-2017
- FDA classification
- Class I
- Brand / firm
- SynCardia Systems Inc.
- Sold / distributed
- US distribution to Virginia and Arizona.
Why it was 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.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
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