# FDA recall Z-0123-2020

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

## Product

Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers:  SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)

## 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-0123-2020
- **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-0123-2020

## Citation

> AI Analytics. FDA recall Z-0123-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0123-2020. Source: US FDA. Licensed CC0.

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