Z-0627-2011

Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CA Indicated...

Name: Z-0627-2011 Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CA Indicated...
Creator: Boston Scientific Corporation
Published: 2010-08-25
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-08-25 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CA Indicated for use in improving cerebral artery lumen diameter... on 2010-08-25. The reason FDA records is "Products may not meet radial force specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0627-2011
Status: Terminated
Initiated: 2010-08-25
Posted: 2010-12-16
Terminated: 2010-12-17
Recalling firm: Boston Scientific Corporation
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.
Product code: NJE Intracranial Neurovascular Stent
Reason for recall: Products may not meet radial force specifications.
Root cause tag: manufacturing process
FDA 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 in commerce: 10 units
Distribution: International Distribution Only -- China, Germany, Italy, the Philippines, Portugal and Turkey.
Product codes and lots: Batch numbers 13215033 and 13192372, Catalog/product UPN number M003WE0300150

Product code NJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)