Rebel Monorail PtCr Coronary Stent System — Class II medical device recall Z-0580-2020
Terminated recall by Boston Scientific Corporation, reported 2019-12-04, distributed nationwide. Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrop
| Recall number | Z-0580-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2019-10-24 |
| Classified | 2019-11-26 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2023-03-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 14,145 devices |
| UPC / GTIN / UDI-DI | 08714729843443 |
| Model numbers | H7493927324300 |
Product
Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.
Reason for recall
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
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-0580-2020. 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.