Recall record at a glance
| Official record | Z-3137-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medtronic Vascular Galway DBA Medtronic Ireland |
| Report date | Sep 27, 2017 |
| Recall initiation date | Jul 13, 2017 |
| Quantity | 105,633 (OUS) |
| Location | Galway, N/A, Ireland |
Official product description
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Why the product was recalled
Stylette removal difficulties on the Euphora and Solarice products.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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