# FDA recall Z-3136-2017

> **Medtronic Vascular Galway DBA Medtronic Ireland** · Class II · device recall initiated 2017-07-13.

## Product

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

## Reason for recall

Stylette removal difficulties on the Euphora and Solarice products.

## Distribution

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

## Key facts

- **Recall number:** Z-3136-2017
- **Recalling firm:** Medtronic Vascular Galway DBA Medtronic Ireland
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-13
- **Report date:** 2017-09-27
- **Termination date:** 2020-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Galway, N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3136-2017

## Citation

> AI Analytics. FDA recall Z-3136-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-3136-2017. Source: US FDA. Licensed CC0.

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