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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 August 20, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on October 24, 2005
Recall Number Z-0031-04
Recall Event ID 27231
PMA Number P860019 
Product Classification Catheters, Transluminal Coronary Angioplasty, Percutaneous - Product Code LOX
Product Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Code Information Lots 5685024 and 5685027 
Recalling Firm/
Manufacturer		 Boston Scientific Scimed
One Scimed Place
Maple Grove MN 55311-1566
For Additional Information Contact Michelle Gudith
763-494-1194
Manufacturer Reason
for Recall		 Some of the recalled catheters have a component that has levels of pyrogens above specification.
FDA Determined
Cause 2		 Other
Action Consignees were sent a recall letter dated August 20, 2003. The letter requested that consignees discontinue use of the catheters from the affected lots and return them.
Quantity in Commerce 6 catheters
Distribution The recalled products were distributed 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 = LOX and Original Applicant = SCIMED LIFE SYSTEMS, INC.
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