FDAFDA · Food and drugs·Recall number Z-0083-2014
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Published November 6, 2013 · Recall initiated: September 19, 2012
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
Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Vascular, Inc.
- Distributor
- 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.
- Lot
- TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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