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U.S. Department of Health and Human Services

Medical Device Recalls

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 Class 2 Recall
PROTEGE EVERFLEX SELFEXPANDING BILIARY STENT SYSTEM
see related information
Date Posted December 01, 2009
Recall Status1 Terminated on March 08, 2012
Recall Number Z-0478-2010
Recall Event ID 53867
Premarket Notification
510(K) Number
K060057 
Product Classification Catheter, Biliary, Diagnostic - Product Code FGE
Product Prot?g? EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. Prot?g? EverFlex" Self-Expanding Peripheral Stent System (for Outside United States distribution). 6 x 100mm, Model Number PRP35-06-100-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. In the United States, the stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the United States, it is intended indicated 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, superficial femoral, proximal popliteal, or subclavian arteries.
Code Information United States lot # 7821740 and Outside United States lot # 7821736
Recalling Firm/
Manufacturer
Ev3, Inc.
4600 Nathan Ln N
Plymouth, Minnesota 55442-2890
Manufacturer Reason
for Recall
ev3 has determined that a lot of 150mm Prot?g? EverFlex Biliary Stent System contains a 100mm length Self-Expanding stent. The implantation of a stent 50mm shorter than expected may not cover the full length of the target lesion and may require subsequent intervention.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Two separate letters were sent to United States and international consignees on November 9, 2009. The letter to US consignees was addressed to Cath Lab Managers while the letter to foreign consignees was addressed to the Risk Manager or Cath Lab Manager. The letters described the affected product, gave an Issue Summary and Required Action, which advised consignees to locate and remove the recalled product. An Ev3, Inc. sales representative will contact consignees to arrange return of all unused product to Ev3, Inc. Direct questions regarding the recall to Ev3, Inc. by calling Customer Service at 1-800-716-6700.
Quantity in Commerce 6 (United States) and 6 (Outside United States)
Distribution Worldwide Distribution -- United States (TX and FL), GERMANY, FRANCE and UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = EV3 INC.
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