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U.S. Department of Health and Human Services

Class 2 Device Recall Matrix2

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 Class 2 Device Recall Matrix2see related information
Date Initiated by FirmFebruary 07, 2007
Date PostedMarch 29, 2007
Recall Status1 Terminated 3 on November 27, 2007
Recall NumberZ-0668-2007
Recall Event ID 37384
510(K)NumberK050700 
Product Classification vascular embolization device - Product Code HCG
ProductMatrix2 Detachable Coils, vascular embolization device. Catalog Number: 497204SR, UPN: M003497204SR0, Catalog Number: 494203, UPN: M0034942030, Distributed and Manufactured by Boston Scientific Corporation, Neurovascular Division, Fremont, CA
Code Information Batch Numbers: 8941830 and 8852539
Recalling Firm/
Manufacturer		 Boston Scientific Target
47900 Bayside Pkwy
Fremont CA 94538-6515
Manufacturer Reason
for Recall		The product may be missing the temperature indicator label on the inner pouch.
FDA Determined
Cause 2		Other
ActionThe firm initiated the recall on 02/07/2007, and initially notified consignees via letter.
Quantity in Commerce57 units
DistributionWorldwide including USA, Argentina, Australia, Brazil, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Netherlands, and New Zealand.
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.
510(K) Database510(K)s with Product Code = HCG
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