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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMarch 17, 2003
Date PostedApril 22, 2003
Recall Status1 Terminated 3 on July 02, 2004
Recall NumberZ-0778-03
Recall Event ID 25947
Product Classification Stent, Coronary - Product Code MAF
ProductN/A
Code Information N/A
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
ActionConsignees 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.
DistributionNationwide in the United States
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.
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