Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Euphora Rapid Exchange Balloon Dilatation Catheter Recalled by Medtronic Vascular Galway DBA Medtronic Ireland Due to Stylette removal difficulties on the Euphora and Solarice...

Date: July 13, 2017
Company: Medtronic Vascular Galway DBA Medtronic Ireland
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Vascular Galway DBA Medtronic Ireland directly.

Affected Products

Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.

Quantity: 69,081 (US)

Why Was This Recalled?

Stylette removal difficulties on the Euphora and Solarice products.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Vascular Galway DBA Medtronic Ireland

Medtronic Vascular Galway DBA Medtronic Ireland has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report