# FDA recall Z-0122-2020

> **Medtronic Vascular Galway DBA Medtronic Ireland** · Class II · device recall initiated 2019-09-03.

## 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.

## Distribution

worldwide

## Key facts

- **Recall number:** Z-0122-2020
- **Recalling firm:** Medtronic Vascular Galway DBA Medtronic Ireland
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-09-03
- **Report date:** 2019-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Galway, N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0122-2020

## Citation

> AI Analytics. FDA recall Z-0122-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0122-2020. Source: US FDA. Licensed CC0.

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