Solarice Rapid Exchange Balloon Dilatation Catheter — Class II medical device recall Z-0123-2020
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-0123-2020 |
|---|---|
| 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 | 98,675 units |
| UPC / GTIN / UDI-DI | 00643169680005, 00643169680012, 00643169680029, 00643169680036, 00643169680043, 00643169680050, 00643169680067, 00643169680074, 00643169680081, 00643169680098, 00643169680104, 00643169680111, 00643169680135, 00643169680159, 00643169680166, 00643169680173, 00643169680180, 00643169680197, 00643169680203, 00643169680210, 00643169680227, 00643169680234, 00643169680241, 00643169680265, 00643169680272 and 19 more |
| Lot numbers | 217218108, 217218110, 217218112, 217218115, 217218119, 217218122, 217218124, 217246454, 217246455, 217246456, 217246457, 217246458, 217246459, 217253571, 217253572, 217253573, 217253574, 217253575, 217253577, 217253578, 217253579, 217253580, 217253581, 217253582, 217271251, 217271252, 217271253, 217271254, 217271255, 217271256, 217271257, 217297544, 217297545, 217298666, 217298667, 217298668, 217298669, 217298670, 217306220, 217306221 and 226 more |
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.
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-0123-2020. 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.