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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Scimed

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  Class 2 Device Recall Boston Scientific Scimed see related information
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
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.
PMA Database PMAs with Product Code = MAF and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.
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