—#94345

Product

Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CA Indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with less than or equal to 50% stenosis that are accessible to the system.

FDA product code: NJE — Intracranial Neurovascular Stent
Device class: Class f
Medical specialty: Unknown
Affected lot / code info: Batch numbers 13215033 and 13192372, Catalog/product UPN number M003WE0300150

Why it was recalled

Products may not meet radial force specifications.

Root cause (FDA determination)

Process control

Action the firm took

Recall initiated August 25, 2010. "Urgent Medical Device Recall - Immediate Action Required" notifications, dated 25 August 2010, were delivered by FedEx where possible, and by personal delivery assigned to sales representatives. The letter identified the affected product and the reason for recall. The letter stated that further distribution or use of any remaining product should cease immediately. Customers were asked to read the enclosed instructions and told that their local Sales Rep could answer any questions that they may have regarding the recall.

Recalling firm

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

Distribution

Distribution pattern: International Distribution Only -- China, Germany, Italy, the Philippines, Portugal and Turkey.

Timeline

Recall initiated: 2010-08-25
Posted by FDA: 2010-12-16
Terminated: 2010-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94345. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.