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U.S. Department of Health and Human Services

Class 2 Device Recall Protege GPS Biliary Stent System

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  Class 2 Device Recall Protege GPS Biliary Stent System see related information
Date Initiated by Firm June 10, 2005
Date Posted June 25, 2005
Recall Status1 Terminated 3 on November 17, 2005
Recall Number Z-0936-05
Recall Event ID 32459
510(K)Number K033314  
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Product ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-10-30-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.
Code Information 1179173
Recalling Firm/
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact Michael D. Geary
Manufacturer Reason
for Recall
A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.
FDA Determined
Cause 2
Action ev3 representative went to the 2 hospitals to retrieve affected product on 06/10/05, completed a Field Action Form and left a copy with the hospital.
Quantity in Commerce 1
Distribution FL and PA
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 = EV3 INC