Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Class I - DangerousWhat Should You Do?
- Check if you have this product: TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Vascular, Inc.
- Reason for Recall:
- Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Product Codes/Lot Numbers:
TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0083-2014
Related Recalls
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Medtronic Vascular
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.