ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
FDA Recall Z-0878-2015 · Posted 2014-12-29
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Recalling FirmEv3, Inc.
Recall StatusTerminated
Product CodeNIM
Date Initiated2014-12-04
Date Terminated2015-07-17
Product Quantity14
Reason for Recall
Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.
Firm Action
Consignees were sent on 12/4/2014 a Covidien "Urgent Field Safety Notice" letter dated 4th December 2014. The letter described the problem and the product involved in the recall. Advised consignees to quarantine, discontinue use of the device and return the product to Covidien. They also requested consignees to complete the "Recall Verification Form" and return it to Covidien. For questions, customers can contact their local Covidien Representative.
Root Cause
Packaging process control
Distribution Pattern
International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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