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U.S. Department of Health and Human Services

Class 2 Device Recall Protg Rx Tapered Carotid Stent System

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  Class 2 Device Recall Protg Rx Tapered Carotid Stent System see related information
Date Initiated by Firm December 04, 2014
Date Posted December 29, 2014
Recall Status1 Terminated 3 on July 17, 2015
Recall Number Z-0879-2015
Recall Event ID 69965
PMA Number P060001 
Product Classification Stent, carotid - Product Code NIM
Product ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, 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.
Code Information Lot # 9922795
Recalling Firm/
Manufacturer		 Ev3, Inc.
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact Rhonda Luniak
303-305-2263
Manufacturer 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.
FDA Determined
Cause 2		 Packaging process control
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.
Quantity in Commerce 24
Distribution International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NIM and Original Applicant = MEDTRONIC VASCULAR INC
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