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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific/Target ascular

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  Class 2 Device Recall Boston Scientific/Target ascular see related information
Date Initiated by Firm June 23, 2003
Date Posted July 19, 2003
Recall Status1 Terminated 3 on October 03, 2018
Recall Number Z-1034-03
Recall Event ID 26601
510(K)Number K955293  
Product Fibered Platinum Coil, 0.035 Type,
9 mm x 60 mm
Catalog no. 372906
Code Information Lot Number: 5472234
Recalling Firm/
Boston Scientific Corporation
1 Boston Scientific Place
Natick MA 01760
For Additional Information Contact Arthur Friedman
Manufacturer Reason
for Recall
Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa
FDA Determined
Cause 2
Action Boston Scientific notified sales representatives on 6/23/03 in foreign distribution area to remove product from inventory and contact hospital to retrieve and return.
Quantity in Commerce 30 units
Distribution Japan, Italy, France, Turkey, Israel, Finland

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 = and Original Applicant = TARGET THERAPEUTICS