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.
- Company
- Boston Scientific Corporation
- Recall Initiated
- August 25, 2010
- Posted
- December 16, 2010
- Terminated
- December 17, 2010
- Recall Number
- Z-0627-2011
- Quantity
- 10 units
- Firm Location
- Fremont, CA
Reason for Recall
Products may not meet radial force specifications.
Distribution
International Distribution Only -- China, Germany, Italy, the Philippines, Portugal and Turkey.
Lot / Code Info
Batch numbers 13215033 and 13192372, Catalog/product UPN number M003WE0300150
Root Cause
Process control
Action Taken
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.