Recall Z-1168-2021 ยท FDI Snare, Flexible
Boston Scientific Corporation
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10), M00562450; M00562401 (Box 10), M00562400; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 1
| 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
| K202478 | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares Boston Scientific Corporation, Oct 8, 2020 |