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Terminated

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

FDA Recall Z-0083-2014 · Posted 2013-10-25

Recalling FirmMedtronic Vascular, Inc.
Recall StatusTerminated
Product CodeMIH
Date Initiated2012-09-19
Date Terminated2013-10-25
Product Quantity~1000

Reason for Recall

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

Firm Action

A Medical Device Information letter was sent to all affected customers on September 19, 2012. Additionally, all Medtronic Field Representatives were notified of the issue via a Field Memo

Root Cause

Component design/selection

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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