FDA-Device2017-09-27Class II
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Medtronic Vascular Galway DBA Medtronic Ireland
Hazard
Stylette removal difficulties on the Euphora and Solarice products.
Sold states
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 BRITAIN, GREECE, GUADELOUPE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KOREA, LATVIA, LEBANON, LIECHTENSTEIN, LITHUANIA, MALAYSIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PAPUA NEW GUINEA, PHILIPPINES, POLAND, PORTUGAL, REUNION, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM and VIET NAM
Affected count
69,081 (US)
Manufactured in
Parkmore Business Park West, N/A, Galway, N/A, Ireland
Products
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3136-2017Don't want to check this manually?
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