Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No — Class II medical device recall Z-0286-2021
Ongoing recall by Boston Scientific Corporation, reported 2020-11-04, distributed nationwide. RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
| Recall number | Z-0286-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2020-09-16 |
| Classified | 2020-10-23 |
| Reported by FDA | 2020-11-04 |
| Distributed | Nationwide (US) |
| Reason classes | potency, device malfunction |
| UPC / GTIN / UDI-DI | 08714729283805, 08714729283812, 08714729283829, 08714729283836, 08714729283843, 08714729283850, 08714729283867, 08714729283874 |
| Lot numbers | 25305803, 25317077, 25326193, 25326194, 25326195, 25326196, 25326198, 25326199, 25326220, 25326221, 25326222, 25334817, 25334818, 25334819, 25334980, 25344165, 25344168, 25344169, 25344170, 25344171, 25366542, 25366543, 25366544, 25366545, 25366546, 25366547, 25366548, 25366549, 25366550, 25378999, 25379240, 25379241, 25392546, 25392549, 25392551, 25392553, 25392554, 25392555, 25392556, 25392557 and 330 more |
| Model numbers | M00545890, M00545900, M00545910, M00545920, M00545930, M00545940, M00545950, M00545960 |
| Expiration dates | 2022-02-08 |
Product
Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.
Reason for recall
RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
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-0286-2021. 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.