Recall Z-0757-2021 ยท FAD Stent, Ureteral
Boston Scientific Corporation
Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
| Date | Nov 16, 2020 |
| Status | Open, Classified |
| Reason | Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel. |
| Root cause | Process design |
| Action | On November 16, 2020, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were informed of the product issue and asked to take the following actions: - Verify whether you have any product from the affected lots/batches within your inventory - Immediately cease use or distribution of any remaining unused product from the affected lots/batches - Segregate affected material and return it to BSC in accordance with removal instructions included in the letter. - Distributors should forward the notification to their customers Your local Sales Representative |
| Quantity | 458 units |
| Distribution | Distribution US nationwide and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974541 | MODIFIED URETERAL INDWELLING CATHETER/STENT Boston Scientific Corp, Feb 9, 1998 |