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Terminated

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 Recall Z-0627-2011 · Posted 2010-12-16

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeNJE
Date Initiated2010-08-25
Date Terminated2010-12-17
Product Quantity10 units

Reason for Recall

Products may not meet radial force specifications.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

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

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