—#83602

Product

Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA.

FDA product code: NJE — Intracranial Neurovascular Stent
Device class: Class f
Medical specialty: Unknown
Affected lot / code info: Batch numbers 8048028 and 8048029.

Why it was recalled

Mislabeling-- Product was placed in a carton, which has printed on it the name of another product. A correct product label was placed on the carton.

Root cause (FDA determination)

Employee error

Action the firm took

The firm issued an Urgent Product Field Action Notice to all listed customers, along with a reply verification form, requesting the return of affected products.

Recalling firm

Firm: Boston Scientific Corporation
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: International Distribution Only -- Countries of Germany, Great Britain, France, Ireland, and Italy.

Timeline

Recall initiated: 2009-05-08
Posted by FDA: 2009-09-09
Terminated: 2009-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83602. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.