Neuroform 3 Microdelivery Stent System; Distributed and manufactured by: Boston Scientific Corporation, Fremont, CA
- Company
- Boston Scientific Corporation
- Recall Initiated
- March 1, 2010
- Posted
- November 26, 2010
- Terminated
- November 26, 2010
- Recall Number
- Z-0482-2011
- Quantity
- 638 units
- Firm Location
- Fremont, CA
Reason for Recall
The product may contain manufacturing aids (mandrels) which should not be present in the final product. If the mandrel remains in place, the catheter cannot be loaded over the required guidewire, so cannot be used.
Distribution
Worldwide Distribution: Throughout the US and to the countries of: Austria, Australia, Belgium, Brazil, Canada, China, Columbia, Czech Republic, Germany, Denmark, Ecuador, Spain, France, Great Britain, Greece, Hungary, India, Ireland, Italy, South Korea, Luxemburg, Mexico, the Netherlands, New Zealand, Peru, Russian Federation, Sweden, Slovenia, Taiwan and Ukraine.
Lot / Code Info
Model number: M003E3400300; expiration date October 2012 UPN Batch UPN Batch M003E3300150 12907487 M003E3400150 12954887 M003E3300200 12915007 M003E3400200 12954888 M003E3350200 12915008 M003E3400300 12958309 M003E3450200 12915009 M003SNF330200 12965212 M003SNF330200 12915010 M003SNF335200 12965215 M003SNF340200 12915011 M003SNF335300 12968779 M003SNF345200 12915013 M003SNF335200 12969012 M003E3300300 12922996 M003SNF345300 12969013 M003E3350200 12923544 M003E3450150 12973549 M003E3300200 12925243 M003E3300200 12976185 M003E3400200 12925245 M003E3350300 12976374 M003E3400300 12925248 M003E3450200 12976378 M003E3450300 12925252 M003SNF330200 12978991 M003SNF325200 12929490 M003SNF335200 12969012 M003SNF30150 12929491 M003SNF340200 12979305 M003SNF335200 12929492 M003E3300200 12983886 M003SNF340200 12929494 M003SNF345300 12982462 M003SNF330150 12929491 M003E3400150 12990085 M003SNF345200 12929492 M003E3400200 12990088 M003SNF340200 12929494 M003E34000300 12990098 M003SNF340300 12929495 M003E3450200 12990124 M003SNF325200 12932459 M003SNF330200 12993187 M003SNF345200 12932945 M003SNF335150 12993189 M003SNF345300 12932946 M003SNF340200 12993190 M003E3350200 12936662 M003SNF340300 12993193 M003E3400200 12936665 M003E3350200 12996254 M003E3450150 12936668 M003SNF34150 12996255 M003E3450200 12940485 M003SNF335200 12996436 M003E3450300 12940950 M003E3400150 13010766 M003SNF335150 12943248 M003E3450300 13010770 M003SNF335200 12943594 M003SNF325200 13010771 M003SNF340200 12943598 M003SNF330150 13010772 M003E3250200 12947325 M003E3350200 13013322 M003E3300200 12947486 M003E3350300 13013323 M003E3450300 12947611 M003SNF335200 13017103 M003E3350200 12950991 M003SNF335200 12969012 M003SNF325150 12950988 M003SNF345300 12950989
Root Cause
Process control
Action Taken
Boston Scientific issued an Urgent Customer Notice dated March 1, 2010 to all US customers, with personal delivery by sales representative where applicable outside the US, identifying the affected device. Customers were instructed to return the device for replacement, and to return an acknowledgement form. Customers can contact Deborah Springer at Boston Scientific at 800-845-4598 about this recall.