Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy… — Class II medical device recall Z-1170-2021
Ongoing recall by Boston Scientific Corporation, reported 2021-03-10, distributed nationwide. Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
| Recall number | Z-1170-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2021-01-19 |
| Classified | 2021-03-04 |
| Reported by FDA | 2021-03-10 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 08714729158110, 08714729158141, 08714729158158, 08714729268802, 08714729268819, 08714729268826, 08714729283904, 08714729283928, 08714729501664, 08714729501671, 08714729747598, 08714729747611, 08714729748069, 08714729748083, 08714729748106 |
| Lot numbers | 24685764, 24685766, 24697822, 24699218, 24699718, 24709534, 24739587, 24739786, 2475126, 24758832, 24817145, 24818278, 24818605, 24824132, 24824134, 24824136, 24835709, 24856636, 24861739, 24861901, 24872119, 24890051, 24899710, 24906823, 24909214, 24909216, 24927642, 24929431, 24939626, 24942292, 24994171, 24995438, 25006729, 25006735, 25023203, 25023343, 25023345, 25042455, 25048397 |
Product
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; M00562693 (Box 40), M00562690.
Reason for recall
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1170-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.