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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 July 01, 2003
Date Posted August 12, 2003
Recall Status1 Terminated 3 on December 28, 2006
Recall Number Z-1112-03
Recall Event ID 26708
510(K)Number K021735  
Product Classification unknown device name - Product Code GBR
Product Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-7020
Code Information Lot numbers 5463705 and 5464511 
Recalling Firm/
Boston Scientific Scimed
One Scimed Place
Maple Grove MN 55311-1566
For Additional Information Contact Patrick Burt
Manufacturer Reason
for Recall
Some of the product pouches have holes in the seals.
FDA Determined
Cause 2
Action Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Quantity in Commerce 17
Distribution The recalled products were shipped to hospitals located nationwide in the United States.

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.
510(K) Database 510(K)s with Product Code = GBR and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.