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U.S. Department of Health and Human Services

Class 2 Device Recall VisiPro" Peripheral Stent System

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 Class 2 Device Recall VisiPro" Peripheral Stent Systemsee related information
Date Initiated by FirmJuly 01, 2008
Date PostedSeptember 26, 2008
Recall Status1 Terminated 3 on December 10, 2011
Recall NumberZ-1547-2008
Recall Event ID 49366
510(K)NumberK061566 
Product Classification Biliary catheter and accessories - Product Code FGE
Productev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35-07-57-080, PXB35-08-17-080, PXB35-08-17-135, PXB35-08-37-080, PXB35-08-57-080, PXB35-09-17-135 ,PXB35-09-27-080, PXB35-09-27-135, PXB35-09-57-080, PXB35-10-27-135, and PXB35-10-37-080. The Endovascular Company , 4800 Nathan Lane North, Plymouth, MN
Code Information Lot Numbers: 3273766, 3273767, 3509137, 4218926, 4361370, 4472112, 4941116, 5012047, 5282885, and 5834997.
FEI Number 2183870
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
ActionConsignees 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 Commerce66
DistributionWorldwide 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 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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