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U.S. Department of Health and Human Services

Class 2 Device Recall Protege GPS 8mm x 40mm Self Expanding Biliary Stent System

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 Class 2 Device Recall Protege GPS 8mm x 40mm Self Expanding Biliary Stent Systemsee related information
Date Initiated by FirmJune 10, 2009
Date PostedSeptember 08, 2009
Recall Status1 Terminated 3 on December 11, 2011
Recall NumberZ-2022-2009
Recall Event ID 52642
510(K)NumberK033314 
Product Classification Diagnostic Biliary Catheter - Product Code FGE
Productev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Biliary Stent System, Rx Only, and SERB65-08-40-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.
Code Information Lot #5283431
Recalling Firm/
Manufacturer		 Ev3, Inc.
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact
763-398-7000
Manufacturer Reason
for Recall		ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Protege GPS stent but actually contained an 8mm x 40mm stent. This situation can lead to vessel damage or inadequate coverage of the target lesion.
FDA Determined
Cause 2		Labeling mix-ups
ActionConsignees were emailed a letter with a subject heading of "Medical Device Recall". The e-mail was dated June 10, 2009. The letter informed the consignee of the problem and product involved. They requested that any affected devices remaining in inventory be identified and returned and to fill out and return the "Device Recall Field Action Reconciliation Form".
Quantity in Commerce4
DistributionInternational Distribution Only -- Brazil, Uruguay, & Malaysia.
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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