Recall Z-0627-2009 ยท DQY Catheter, Percutaneous
Boston Scientific Corporation
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.
| Date | Oct 7, 2008 |
| Status | Terminated |
| Reason | Packaging issue may result in failure to maintain sterile barrier. |
| Root cause | Package design/selection |
| Action | 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 corre |
| Quantity | 21,423 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013789 | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 Boston Scientific, Target, Dec 6, 2001 |