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U.S. Department of Health and Human Services

Class 3 Device Recall IntraStent DoubleStrut LD Biliary Stent

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 Class 3 Device Recall IntraStent DoubleStrut LD Biliary Stentsee related information
Date Initiated by FirmDecember 29, 2005
Date PostedMay 03, 2006
Recall Status1 Terminated 3 on December 26, 2006
Recall NumberZ-0829-06
Recall Event ID 34357
510(K)NumberK993904 
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
ProductIntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expandable stent. It is intended as a permanently implanted device. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is designed to be crimped onto a non-compliant PTA balloon catheter that is indicated for biliary stent expansion. After mounting onto a balloon catheter, it is deployed and expanded by inflating the balloon.
Code Information Model S15-36, lot no. 494428
FEI Number 2183870
Recalling Firm/
Manufacturer		 Ev3, Inc
4600 Nathan Ln N
Plymouth MN 55442-2890
Manufacturer Reason
for Recall		IntraStent product S15-36 (P/N 90-1341-02) lot 494428 was labeled as IntraStent product S15-26 (P/N 90-1341-001)
FDA Determined
Cause 2		Other
ActionOn March 3, 2004, shipping personnel noted that IntraStent product S15-36, lot 494428, was labeled as IntraStent product S15-26. Six units from the lot were in distribution. On December 29, 2005, customers were sent a Field Action Form to record the number of used or available for return stents at their facility. The form instructs the customer to return the completed original form and any unused stents.
Quantity in Commerce6 devices
DistributionAR, GA, IN, MA, TN, and UT
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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