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U.S. Department of Health and Human Services

Class 2 Device Recall Protege GPS SelfExpanding Nitinol Stent Biliary System

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  Class 2 Device Recall Protege GPS SelfExpanding Nitinol Stent Biliary System see related information
Date Initiated by Firm February 27, 2006
Date Posted March 18, 2006
Recall Status1 Terminated 3 on December 26, 2006
Recall Number Z-0707-06
Recall Event ID 34858
510(K)Number K011806  
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Product ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3, 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The self-expanding stent is made of nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. The stent is cut from a nitinol tube into an open lattice design and is designed with 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 in the biliary ducts.
Code Information Lot 1211723, expiration date Nov 2007
Recalling Firm/
Manufacturer		 Ev3, Inc
4600 Nathan Ln N
Plymouth MN 55442-2890
Manufacturer Reason
for Recall		 Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected.
FDA Determined
Cause 2		 Other
Action An ev3 field representative will notify affected consignees in person beginning 2/27/2006. Product retrieval or use of the device will be documented using on a ''Field Action Form''. Account credit or product from an unaffected lot number will be provided.
Quantity in Commerce 4
Distribution GA, OK and TX
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.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = SULZER INTRATHERAPEUTICS, INC.
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