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U.S. Department of Health and Human Services

Class 2 Device Recall Wingspan Stent System

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  Class 2 Device Recall Wingspan Stent System see related information
Date Initiated by Firm August 25, 2010
Date Posted December 16, 2010
Recall Status1 Terminated 3 on December 17, 2010
Recall Number Z-0627-2011
Recall Event ID 56716
HDE Number H050001 
Product Classification Intracranial Neurovascular Stent - Product Code NJE
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.
Code Information Batch numbers 13215033 and 13192372, Catalog/product UPN number M003WE0300150
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact
510-624-2544
Manufacturer Reason
for Recall		 Products may not meet radial force specifications.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
HDE Database HDEs with Product Code = NJE and Original Applicant = STRYKER CORP.
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