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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 Systemsee related information
Date Initiated by FirmDecember 06, 2006
Date PostedFebruary 01, 2007
Recall Status1 Terminated 3 on February 03, 2007
Recall NumberZ-0389-2007
Recall Event ID 37006
510(K)NumberK033314 
Product Classification stent - Product Code FGE
Productev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.
Code Information Lot 1772812
FEI Number 2183870
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
ActionLetter 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 Commerce2
DistributionIL, PA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FGE
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