Valiant Thoracic Stent Graft with Captivia Delivery recall
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Why was Valiant Thoracic Stent Graft with Captivia Delivery recalled?
Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
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?
TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.
- Product
- Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
- Recalling firm
- Medtronic Vascular, Inc.
- Quantity
- ~1000
- Distribution
- International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom.
- Recall date
- November 6, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)