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Terminated

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

FDA Recall Z-0668-2007 · Posted 2007-03-29

Recalling FirmBoston Scientific Target
Recall StatusTerminated
Product CodeHCG
Date Initiated2007-02-07
Date Terminated2007-11-27
Product Quantity57 units

Reason for Recall

The product may be missing the temperature indicator label on the inner pouch.

Firm Action

The firm initiated the recall on 02/07/2007, and initially notified consignees via letter.

Root Cause

Other

Distribution Pattern

Worldwide including USA, Argentina, Australia, Brazil, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Netherlands, and New Zealand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050700MATRIX STRETCH RESISTANT (SR) COILSBoston Scientific Corp · 2005-04-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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