SpyScope DS Access and Delivery diagnostic biliary catheter — Class II medical device recall Z-1133-2018
Terminated recall by Boston Scientific Corporation, reported 2018-03-28, distributed nationwide. Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in
| Recall number | Z-1133-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2017-12-20 |
| Classified | 2018-03-19 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2019-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BH, BR, CA, CH, CN, CZ, DE, DK, EC, ES, FI, FR, GB, GT, HK, HU, IE, IL, IN, IT, KR, MX, MY, NL, NO, PE, PK, PL, PT, QA, RO, SA, SE, SG, SK, TH, TN, TR, VN, ZA |
| Quantity | 5,026 |
Product
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Reason for recall
Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
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-1133-2018. 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.