FDAFDA · Food and drugs·Recall number Z-0659-2017
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Published December 14, 2016 · Recall initiated: October 21, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- SynCardia Systems Inc.
- Distributor
- US distribution to Virginia and Arizona.
- Lot
- S/N 5002 UDI (01)00858000003121(21)5002 S/N 5005 UDI (01)00858000003121(21)5005 S/N 5008 UDI (01)00858000003121(21)5008 S/N 5009 UDI (01)00858000003121(21)5009 S/N 5010 UDI (01)00858000003121(21)5010
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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