Recall Z-1170-2021 ยท FDI Snare, Flexible
Boston Scientific Corporation
Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M
| 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
| K131700 | SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES Boston Scientific Corp, Nov 4, 2013 |