Recall Z-0627-2011 ยท NJE Intracranial Neurovascular Stent
Boston Scientific Corporation
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.
| Date | Dec 16, 2010 (initiated Aug 25, 2010) |
| Status | Terminated |
| Reason | Products may not meet radial force specifications. |
| Root cause | Process control |
| 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. |
| Quantity | 10 units |
| Distribution | International Distribution Only -- China, Germany, Italy, the Philippines, Portugal and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.