Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Reported: November 6, 2013 Initiated: September 19, 2012 #Z-0083-2014
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.
Details
- Recalling Firm
- Medtronic Vascular, Inc.
- Units Affected
- ~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.
- Location
- Santa Rosa, CA
Frequently Asked Questions
What product was recalled? ▼
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.. Recalled by Medtronic Vascular, Inc.. Units affected: ~1000.
Why was this product recalled? ▼
Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2013. Severity: Moderate. Recall number: Z-0083-2014.
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