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U.S. Department of Health and Human Services

Class 2 Device Recall VisiPro" Biliary Stent System

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  Class 2 Device Recall VisiPro" Biliary Stent System see related information
Date Initiated by Firm July 01, 2008
Date Posted September 26, 2008
Recall Status1 Terminated 3 on December 10, 2011
Recall Number Z-1548-2008
Recall Event ID 49366
510(K)Number K061566  
Product Classification Biliary catheter and accessories - Product Code FGE
Product ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System.

Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27-135 , PXB35-08-37-135, PXB35-08-57-080, and PXB35-09-17-135 4800. The Endovascular Company, Nathan Lane North, Plymouth, MN 55442-2920,
Code Information Lot Numbers: 4089374, 4140341, 4151887, 4194358, 4239470, 4251836, 4484043, 44804047, 4491290, 4933989, 5005731, 5012045, 5045725, 5117532, 5147416, 5149205, 5214432, 5221941, 5239429, and 5577902.
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. has determined that specific lots of the Visi-Pro" BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended.
FDA Determined
Cause 2		 Employee error
Action Consignees were sent a "Medical Device Recall" letter dated 7/1/08. The letter described the product, problem and action to be taken. The letter also requested to complete and return The Field Action Reconciliation Form. For further information, please contact Customer Service at 800-716-6700.
Quantity in Commerce 212
Distribution Worldwide Distribution including states of AL,AZ, CA, CO, CT, FL, IL, IN, IA, KS, KY, LA,ME, MA, MI, MN, MO, MT, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, WV, WI, and VA. Counties of SWEDEN, TUNISIA, SWITZERLAND, GERMANY, ITALY, SLOVENIA, FRANCE, BELGIUM, UNITED KINGDOM, TURKEY, FINLAND, LITHUANIA, and NORWAY.
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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