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U.S. Department of Health and Human Services

Class 2 Device Recall EV3 EverFiex" Selfexpanding Peripheral Stent System

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  Class 2 Device Recall EV3 EverFiex" Selfexpanding Peripheral Stent System see related information
Date Initiated by Firm May 23, 2016
Create Date June 23, 2016
Recall Status1 Terminated 3 on September 22, 2017
Recall Number Z-2048-2016
Recall Event ID 74276
PMA Number P110023 
Product Classification Stent, superficial femoral artery - Product Code NIP
Product EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080.
The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F, 0.035" over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency
Code Information lot: A164580
Recalling Firm/
Manufacturer		 Ev3, Inc.
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact Customer Focused Quality
763-398-7000
Manufacturer Reason
for Recall		 Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding Peripheral Stent Systems, model PRB35-08-040- 080, from lot A164580. The size on the outer box is labeled as 8x40x80mm while potentially containing a 6x40x120mm device as indicated by both the inner pouch and device labels. This potential issue is limited to two EverFiex stent system devices from lot A164580 that were repackaged by Medtronic and distributed. This does not affect any other Medtronic product or implantable devices.
FDA Determined
Cause 2		 Labeling mix-ups
Action Medtronic sent an "Urgent Medical Device Recall" letter dated May 2016, to all affected customers. The letter described the problem and the product involved in the recall. Consignees were instructed to identify, quarantine and return unused product to Medtronic. Consignees were requested to complete the Customer Confirmation Certificate and email it to RS.CFQFCA¿Medtronic.com or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. Customers with questions were instructed to call 651-367-0612. For question regarding this recall call 763-398-7000.
Quantity in Commerce 2
Distribution Nationwide Distribution to LA and WI.
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 = NIP and Original Applicant = MEDTRONIC VASCULAR INC
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