Date Initiated by Firm |
March 17, 2003 |
Date Posted |
April 22, 2003 |
Recall Status1 |
Terminated 3 on July 02, 2004 |
Recall Number |
Z-0777-03 |
Recall Event ID |
25947 |
PMA Number |
P970061 |
Product Classification |
Stent, Coronary - Product Code MAF
|
Product |
Boston Scientific Scimed Radius 3.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500301 |
Code Information |
Lot number 5357125 |
Recalling Firm/ Manufacturer |
Boston Scientific Scimed One Scimed Place Maple Grove MN 55311-1566
|
Manufacturer Reason for Recall |
A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were sent a recall letter dated March 17, 2003. The letter requested that consignees discontinue use of stents from the affected lots and return them. |
Quantity in Commerce |
4 Stent Systems |
Distribution |
Nationwide in the United States |
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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PMA Database |
PMAs with Product Code = MAF and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.
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