Medtronic Vascular Galway DBA Medtronic Ireland recalls Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exch…

Recall date

July 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3137-2017

FDA classification

Class II

Brand / firm

Medtronic Vascular Galway DBA Medtronic Ireland

Sold / distributed

Worldwide distribution. US Nationwide, including Puerto Rico; ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ESTONIA, FRANCE, GERMANY, GREAT BR…

Why it was recalled

Stylette removal difficulties on the Euphora and Solarice products.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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