Recall Z-1429-2021 ยท DQY Catheter, Percutaneous
Boston Scientific Corporation
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.
| Date | Mar 5, 2021 |
| Status | Terminated |
| Reason | The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. |
| Root cause | Labeling False and Misleading |
| Action | A Recall notification letter titled, "Medical Device Removal - Immediate Action Required" was sent to the OUS consignees on 03/05/2021 and the U.S. consignees on 03/08/2021 via overnight mail delivery. Customers outside of the US were either contacted via letter delivery or email. The recalling firm requested if the consignees identify any product from the listed batch within their inventory, to please segregate the product immediately and return it to Boston Scientific in accordance with the enclosed instructions. The consignees will receive replacement product for all removed product returne |
| Quantity | 52 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190401 | MAMBA and MAMBA Flex Microcatheters Boston Scientific Corporation, Mar 15, 2019 |