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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Scimed Express II

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  Class 2 Device Recall Boston Scientific Scimed Express II see related information
Date Initiated by Firm July 16, 2003
Date Posted August 12, 2003
Recall Status1 Terminated 3 on December 28, 2006
Recall Number Z-1123-03
Recall Event ID 26881
PMA Number P020009 
Product Classification Stent, Coronary - Product Code MAF
Product Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235
Code Information Lot 5570485
Recalling Firm/
Manufacturer		 Boston Scientific Scimed
One Scimed Place
Maple Grove MN 55311-1566
For Additional Information Contact Patrick Burt
763-494-1192
Manufacturer Reason
for Recall		 There is an Increased potential for broken struts of the stents.
FDA Determined
Cause 2		 Other
Action Consignees were sent a recall letter dated July 16, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Quantity in Commerce 17 stent systems
Distribution The products were shipped to consignees located 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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