Recall Z-0083-2014— Medtronic Vascular, Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Vascular, Inc., initiated 2012-09-19, terminated 2013-10-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.. Reason: Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU..
- Recalling firm
- Medtronic Vascular, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-19
- Terminated
- 2013-10-25
- Firm location
- Santa Rosa, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.