Euphora Rapid Exchange Balloon Dilatation Catheter — Class II medical device recall Z-3136-2017
Terminated recall by Medtronic Vascular Galway DBA Medtronic Ireland, reported 2017-09-27, distributed nationwide. Stylette removal difficulties on the Euphora and Solarice products.
| Recall number | Z-3136-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular Galway DBA Medtronic Ireland, Galway, N/A, Ireland |
| Recall initiated | 2017-07-13 |
| Classified | 2017-09-20 |
| Reported by FDA | 2017-09-27 |
| Terminated | 2020-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BD, BE, BG, BR, CA, CH, CN, CO, CR, CZ, DE, DO, DZ, EE, ES, FR, GB, GR, HK, HR, HU, IE, IL, IN, IT, JM, JO, JP, KE, KR, LB, LK, LT, LV, MA, MX, MY, NG, NI, NL, NO, OM, PH, PK, PL, PT, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, VN, ZA |
| Quantity | 69,081 |
| UPC / GTIN / UDI-DI | 00006431695600, 00643169559813, 00643169559820, 00643169559837, 00643169559844, 00643169559851, 00643169559868, 00643169559875, 00643169559882, 00643169559899, 00643169559905, 00643169559912, 00643169559929, 00643169559936, 00643169559943, 00643169559950, 00643169559967, 00643169559974, 00643169559981, 00643169559998, 00643169560000, 00643169560017, 00643169560024, 00643169560031, 00643169560048 and 102 more |
| Lot numbers | 006, 212553130, 212561150, 212561152, 212561157, 212561158, 212572471, 212572472, 212572473, 212572474, 212572475, 212572476, 212572477, 212572478, 212572479, 212572600, 212572601, 212572603, 212577123, 212577124, 212577125, 212577126, 212577127, 212577128, 212577129, 212577130, 212577131, 212577155, 212577156, 212577157, 212577158, 212577159, 212577780, 212610517, 212610518, 212610519, 212610560, 212610561, 212610562, 212610563 and 460 more |
Product
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Reason for recall
Stylette removal difficulties on the Euphora and Solarice products.
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-3136-2017. 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.