Excelsior SL-10 Microcatheter, placed in sterile pouch. Manufactured by Boston Scientific Corporation, Fremont, CA. The ExcelsiorTM SL-10 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature.

Packaging issue may result in failure to maintain sterile barrier.

Consignees were notified by letter dated October 7, 2008. The letter identified the issue and affected product. Customers were instructed to: 1.) Discontinue use of and segregate recalled product, 2.) Complete and return the enclosed Reply Verification Tracking Form, and 3.) Package/ship the recalled product and send to the Boston Scientific Corporation (BSC). Return the completed Reply Verification Tracking Form via fax (800-836-4804) to the BSC Customer Service Call Center. A follow-up letter dated October 8, 2008 was also issued to customers. The letter notified customers of the correct date range of expiration for product within the scope of the recall which is September 2008 through October 2010. There were no other changes identified in the follow-up letter.