FDA Device recall Z-3136-2017
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System
- FDA Device
- Class II
- terminated
- Published 2017-09-27
On 2017-09-27 the FDA classified a Class II recall of Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System by Medtronic Vascular Galway, citing stylette removal difficulties on the Euphora and Solarice products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3136-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-13 |
| Published | 2017-09-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Vascular Galway |
| Distribution | US |
Product
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Reason
Stylette removal difficulties on the Euphora and Solarice products.
Identifiers
| code_info | Product Number/CFN GTIN Lot EUP22512X 00643169559950 212561150 EUP3015X 00643169560154 212561157 EUP1512X…Product Number/CFN GTIN Lot EUP22512X 00643169559950 212561150 EUP3015X 00643169560154 212561157 EUP1512X 00643169559837 212561158 EUP1515X 00643169559844 212561152 EUP3015X 00643169618916 212572601 EUP2012X 00643169618527 212572603 EUP2520X 00643169560031 212572479 EUP1510X 00643169618633 212572600 EUP2512X 00643169560017 212572471 EUP22515X 00643169559967 212572472 EUP1515X 00643169618688 212577123 EUP2020X 00643169618442 212577128 EUP27520X 00643169560109 212572474 EUP3020X 00643169560161 212572476 EUP1520X 00643169618923 212577129 EUP2512X 00643169618817 212577127 EUP27515X 00643169618855 212553130 EUP2506X 00643169559998 212572475 EUP2510X 00643169560000 212577156 EUP2510X 00643169618732 212577125 EUP2012X 00643169618527 212577130 EUP2015X 00643169618480 212577124 EUP2010X 00643169618862 212577131 EUP2020X 00643169559905 212610574 EUP2512X 00643169560017 212577157 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3136-2017%22
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