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FDA Medical Device Recalls (openFDA)

Boston Scientific Target: Matrix2 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

Recall number
Z-0668-2007
Recalling firm
Boston Scientific Target
Product
Matrix2 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
Status
Terminated
Initiated
2007-02-07
Posted
2007-03-29
Terminated
2007-11-27
Reason
The product may be missing the temperature indicator label on the inner pouch.
Root cause
Other
Action
The firm initiated the recall on 02/07/2007, and initially notified consignees via letter.
Quantity
57 units
Distribution
Worldwide including USA, Argentina, Australia, Brazil, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Netherlands, and New Zealand.
Lot, serial or model codes
Batch Numbers: 8941830 and 8852539
510(k) numbers
["K050700"]
PMA numbers
not on file
Product code
HCG
Firm FEI
2939204
Firm city
Fremont
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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