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U.S. Department of Health and Human Services

Class 3 Device Recall Protege GPS Biliary Stent System

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  Class 3 Device Recall Protege GPS Biliary Stent System see related information
Date Initiated by Firm December 06, 2006
Date Posted February 01, 2007
Recall Status1 Terminated 3 on February 03, 2007
Recall Number Z-0389-2007
Recall Event ID 37006
510(K)Number K033314  
Product Classification stent - Product Code FGE
Product ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.
Code Information Lot 1772812
Recalling Firm/
Manufacturer		 Ev3, Inc
4600 Nathan Ln N
Plymouth MN 55442-2890
Manufacturer Reason
for Recall		 Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected.
FDA Determined
Cause 2		 Other
Action Letter 12/06/2006. An ev3 representative visited the affected hospital to determine the status of the recalled device. If the device is unused, the representative is to retrieve the device for return to ev3. The representative is to complete the Device Recall Field Action Form, along with a hospital representative signature, and fax the completed form to ev3.
Quantity in Commerce 2
Distribution IL, 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
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