Euphoria Rapid Exchange Balloon Dilatation Catheter — Class II medical device recall Z-0122-2020
Ongoing recall by Medtronic Vascular Galway DBA Medtronic Ireland, reported 2019-10-23. Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficul
| Recall number | Z-0122-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular Galway DBA Medtronic Ireland, Galway, N/A, Ireland |
| Recall initiated | 2019-09-03 |
| Classified | 2019-10-11 |
| Reported by FDA | 2019-10-23 |
| Quantity | 53,137 units |
| UPC / GTIN / UDI-DI | 00643169559813, 00643169559820, 00643169559837, 00643169559844, 00643169559851, 00643169559868, 00643169559875, 00643169559882, 00643169559899, 00643169559905, 00643169559912, 00643169559929, 00643169559936, 00643169559943, 00643169559950, 00643169559967, 00643169559974, 00643169559981, 00643169559998, 00643169560000, 00643169560017, 00643169560024, 00643169560031, 00643169560048, 00643169560055 and 137 more |
| Lot numbers | 217216700, 217216701, 217216702, 217225123, 217225124, 217225125, 217225186, 217225187, 217225188, 217225189, 217225190, 217225191, 217225192, 217225193, 217225194, 217232723, 217232724, 217232725, 217238066, 217238067, 217238068, 217238069, 217238070, 217239780, 217239781, 217239782, 217239783, 217239784, 217246460, 217246461, 217246462, 217246463, 217246464, 217246465, 217253537, 217253538, 217253539, 217253643, 217253644, 217253645 and 460 more |
Product
Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP3525X, EUP3530X, EUP37506X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP4006X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X
Reason for recall
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
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-0122-2020. 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.