| Class 2 Device Recall Intrastent Balloon Expandable Biliary Stent |  |
Date Initiated by Firm | January 18, 2008 |
Date Posted | May 06, 2008 |
Recall Status1 |
Terminated 3 on November 04, 2008 |
Recall Number | Z-1130-2008 |
Recall Event ID |
46693 |
510(K)Number | K980290 |
Product Classification |
Biliary Stent - Product Code FGE
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Product | ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-001.
ev3 IntraStent LD Max Large Diameter Peripheral Stent Model Number: S18-26, Catalog Number: 90-2337-001 (not approved within USA). |
Code Information |
Lot Numbers: 1879157, 1940667, 2429814, 2431937, 1646895, 3151708, 3104952, 2601011, 2107071, 2036017, 4206244, 2036018, and 2829735 |
Recalling Firm/ Manufacturer |
Ev3, Inc 4600 Nathan Ln N Plymouth MN 55442-2890
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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 | 203 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = FGE
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