Boston Scientific Corporation Recall 87539
Description: MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
Boston Scientific Corporation Recall 87539 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1429-2021 |
| Event ID | 87539 |
| Event Description | MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton. |
| Product Type | Devices |
| Distribution | Distributed nationwide to AL, AR, AZ, CO, FL, GA, IA, IL, KY, LA, MI, MN, MO, MS, NC, ND, NV, NY, OK, OH, PR, SC, TN, VA, WA, WI and internationally to Belgium, France, Great Britain, Israel, Italy, Lithuania, Netherlands, Poland, Puerto Rico, Switzerland |
| Quantity | 52 devices |
| Recall Reason | The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. |
| Device Classification | 20210421 |
| Device Code Info | UPN: H7493928713540 US (Green); Batches: 26578463 and 26578470; GTIN: 8714729940289; and Expiration Date: 4-Jan-23 |
| Center Classification Date | 20210415 |
| Recall Initiation Date | 20210305 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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