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U.S. Department of Health and Human Services

Class 2 Device Recall Intrastent Balloon Expandable Biliary Stent

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  Class 2 Device Recall Intrastent Balloon Expandable Biliary Stent see related information
Date Initiated by Firm January 18, 2008
Date Posted May 06, 2008
Recall Status1 Terminated 3 on November 04, 2008
Recall Number Z-1120-2008
Recall Event ID 46693
510(K)Number K980290  
Product Classification Biliary Stent - Product Code FGE
Product ev3 IntraStent Biliary Stent, Model Number: S10-26,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0648-001.
Code Information Lot Number: 2099706 
Recalling Firm/
Manufacturer		 Ev3, Inc
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact
763-398-7000
Manufacturer Reason
for Recall		 Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
FDA Determined
Cause 2		 Labeling Change Control
Action ev3 notified all consignees via "Medical Device Recall" letter on 1/18/08. The letter was addressed to the Hospital and it described the device affected and the problem. The letter provided recommendations to segregate the affected devices and requested the return of the "Device Recall Field Action Reconciliation Form."
Quantity in Commerce 2
Distribution Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
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 = INTRATHERAPEUTICS, INC.
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