Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the...

FDA Device Recall #Z-0083-2014 — Class II — September 19, 2012

Recall Summary

Recall Number Z-0083-2014
Classification Class II — Moderate risk
Date Initiated September 19, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medtronic Vascular, Inc.
Location Santa Rosa, CA
Product Type Devices
Quantity ~1000

Product Description

Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.

Reason for Recall

Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.

Distribution Pattern

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 / Code Information

TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.

Other Recalls from Medtronic Vascular, Inc.

Recall # Classification Product Date
Z-1042-2022 Class II Medtronic IN.PACT Admiral, Paclitaxel-coated PT... Mar 23, 2022
Z-1043-2022 Class II Medtronic IN.PACT AV, Paclitaxel-coated PTA Bal... Mar 23, 2022
Z-0657-2022 Class II Endurant, Endurant II and Endurant IIs Stent Gr... Dec 21, 2021
Z-0290-2022 Class II Endurant Stent Graft System REF/Description: ... Oct 15, 2021
Z-0291-2022 Class II Endurant II Stent Graft System REF/Description:... Oct 15, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.