FDA Device recall Z-3137-2017
Solarice 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 Solarice 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-3137-2017 |
| 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
Solarice 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 SLC2525X 00643169680234 212610381 SLC3520X 00643169680449 212610395 SLC1520X 006431696…Product Number / CFN GTIN Lot SLC2525X 00643169680234 212610381 SLC3520X 00643169680449 212610395 SLC1520X 00643169680043 212610391 SLC2015X 00643169680081 212610384 SLC2020X 00643169680098 212621132 SLC2515X 00643169680210 212610388 SLC2520X 00643169680227 212621130 SLC4015X 00643169680531 212610378 SLC27520X 00643169680289 212621127 SLC27515X 00643169680272 212621128 SLC3515X 00643169680432 212621129 SLC3020X 00643169680340 212663250 SLC22510X 00643169680135 212671839 SLC3010X 00643169680319 212663249 SLC22506X 00643169680128 212671834 SLC2506X 00643169680180 212671836 SLC2025X 00643169680104 212671880 SLC37515X 00643169680487 212671833 SLC32515X 00643169680388 212671838 SLC4010X 00643169680517 212671837 SLC22520X 00643169680166 212663251 SLC3006X 00643169680302 212671835 SLC2020X 00643169680098 212691165 SLC2512X 00643169680203 212691118 SLC2515X 00643169680210 212691164 SLC2015X 00643169680081 212691160 SLC22512X 00643169680142 212691163 SLC2025X |
|---|
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-3137-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.