Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CA Indicated for use in i
FDA device recall Z-0627-2011 · posted 2010-12-16 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Products may not meet radial force specifications.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NJE
- Quantity affected
- 10 units
- Distribution
- International Distribution Only -- China, Germany, Italy, the Philippines, Portugal and Turkey.
- Date initiated
- 2010-08-25
- Date posted
- 2010-12-16
- Date terminated
- 2010-12-17
- Location
- Fremont, CA
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