Z-0668-2007

Matrix2 Detachable Coils, vascular embolization device. Catalog Number: 497204SR, UPN: M003497204SR0, Catalog...

Name: Z-0668-2007 Matrix2 Detachable Coils, vascular embolization device. Catalog Number: 497204SR, UPN: M003497204SR0, Catalog...
Creator: Boston Scientific Target
Published: 2007-02-07
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-02-07 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Target began a recall of Matrix2 Detachable Coils, vascular embolization device. Catalog Number: 497204SR, UPN: M003497204SR0, Catalog Number: 494203, UPN: M0034942030, Distributed and... on 2007-02-07. The reason FDA records is "The product may be missing the temperature indicator label on the inner pouch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0668-2007
Status: Terminated
Initiated: 2007-02-07
Posted: 2007-03-29
Terminated: 2007-11-27
Recalling firm: Boston Scientific Corporation
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
Product code: HCG Device, Neurovascular Embolization
Reason for recall: The product may be missing the temperature indicator label on the inner pouch.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm initiated the recall on 02/07/2007, and initially notified consignees via letter.
Quantity in commerce: 57 units
Distribution: Worldwide including USA, Argentina, Australia, Brazil, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Netherlands, and New Zealand.
Product codes and lots: Batch Numbers: 8941830 and 8852539

Product code HCG

K050700Class IIMatrix Stretch Resistant (Sr) CoilsBoston Scientific Corp / cleared 2005-04-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)