Recall Z-1169-2021 ยท FDI Snare, Flexible
Boston Scientific Corporation
Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.
| Date | Jan 19, 2021 |
| Status | Open, Classified |
| Reason | Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient. |
| Root cause | Process change control |
| Action | On 01/21/2021, Boston Scientific issued Urgent Medical Device Product Removal notices to customers via e-mail. The removal notice is due to an incomplete seal of the inner pouch which could result in a sterile barrier breach rendering the specified lots of polypectomy snare devices non-sterile. |
| Quantity | 335,788 units total (Domestic: 222,882, Foreign: 112,906) |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133987 | CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES Boston Scientific Corporation, Jan 24, 2014 |