Boston Scientific Corporation
Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon Catalog # 4545
| Date | Feb 8, 2003 (initiated Jan 29, 2003) |
| Status | Terminated |
| Reason | Breach in sterile barrrier may compromise sterility |
| Root cause | Other |
| Action | Boston Scientific/Microvasive, Natick, MA initiated a voluntary recall by letter dated 1/27/03, and mailed 1/29/03. Accounts were requested to remove affected lots and return product to Boston Scientific. A verification form was provided to monitor effectiveness of the recall notification. Non-reponders will be recontacted. |
| Quantity | 255 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970052 | EXTRACTORRX Boston Scientific Corp, Mar 25, 1997 |