Recall Z-2759-2020 ยท FDI Snare, Flexible
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare
| Date | Jul 6, 2020 |
| Status | Open, Classified |
| Reason | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue. |
| Root cause | Device Design |
| Action | BSC will sent the customer communication package on July 6, 2020. The communication package includes a Customer Letter and a Reply Verification Tracking Form. |
| Distribution | World wide 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 |