Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery Syste
FDA device recall Z-0083-2014 · posted 2013-10-25 · Terminated
Recall details
- Recalling firm
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- MIH
- Quantity 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, P
- Date initiated
- 2012-09-19
- Date posted
- 2013-10-25
- Date terminated
- 2013-10-25
- Location
- Santa Rosa, CA
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