5000 Series Freedom Drivers. Freedom Driver System for recall
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Why was 5000 Series Freedom Drivers. Freedom Driver System for 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
- Recalling firm
- SynCardia Systems Inc.
- Quantity
- 5
- Distribution
- US distribution to Virginia and Arizona.
- Recall date
- December 14, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)