Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA)…
Medical device recall Z-3136-2017. Published in FDA’s Enforcement Report on Sep 27, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 27, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 69,081 (US) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Stylette removal difficulties on the Euphora and Solarice products.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
69,081 (US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Number/CFN GTIN Lot EUP22512X 00643169559950 212561150 EUP3015X 00643169560154 212561157 EUP1512X 00643169559837 212561158 EUP1515X 00643169559844 212561152 EUP3015X 00643169618916 212572601 EUP2012X 00643169618527 212572603…
Every code shown here, 2,000 characters
Product Number/CFN GTIN Lot EUP22512X 00643169559950 212561150 EUP3015X 00643169560154 212561157 EUP1512X 00643169559837 212561158 EUP1515X 00643169559844 212561152 EUP3015X 00643169618916 212572601 EUP2012X 00643169618527 212572603 EUP2520X 00643169560031 212572479 EUP1510X 00643169618633 212572600 EUP2512X 00643169560017 212572471 EUP22515X 00643169559967 212572472 EUP1515X 00643169618688 212577123 EUP2020X 00643169618442 212577128 EUP27520X 00643169560109 212572474 EUP3020X 00643169560161 212572476 EUP1520X 00643169618923 212577129 EUP2512X 00643169618817 212577127 EUP27515X 00643169618855 212553130 EUP2506X 00643169559998 212572475 EUP2510X 00643169560000 212577156 EUP2510X 00643169618732 212577125 EUP2012X 00643169618527 212577130 EUP2015X 00643169618480 212577124 EUP2010X 00643169618862 212577131 EUP2020X 00643169559905 212610574 EUP2512X 00643169560017 212577157 EUP3012X 00643169560147 212577155 EUP2006X 00643169559868 212577159 EUP27515X 00643169560093 212572477 EUP27512X 00643169560086 212577158 EUP2010X 00643169559875 212610579 EUP3515X 00643169560284 212572478 EUP2006X 00643169559868 212610578 EUP22520X 00643169559974 212610565 EUP22512X 00643169559950 212610575 EUP22510X 00643169559943 212610572 EUP3010X 00643169560130 212610518 EUP3006X 00643169560123 212610566 EUP3520X 00643169560291 212610564 EUP2512X 00643169560017 212613013 EUP2520X 00643169560031 212613011 EUP1506X 00643169559813 212577780 EUP1515X 00643169559844 212610576 EUP2030X 00643169559929 212610567 EUP2515X 00643169618435 212577126 EUP2015X 00643169559899 212610577 EUP2512X 00643169560017 212610569 EUP2515X 00643169560024 212610563 EUP2530X 00643169560055 212613004 EUP3512X 00643169560277 212610560 EUP1506X 00643169559813 212613006 EUP2510X 00643169560000 212613009 EUP3515X 00643169560284 212610573 EUP3020X 00643169560161 212613010 EUP3510X 00643169560260 212613005 EUP27512X 00643169560086 212613012 EUP4015X 00643169560413 212610517 EUP3015X 00643169560154 212613003 EUP4012X 00643169560406…
FDA’s list runs to 46,202 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 13, 2017.
- FDA classified it on Sep 20, 2017.
- FDA’s Enforcement Report published it on Sep 27, 2017.
- FDA terminated it on Aug 19, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Vascular Galway DBA Medtronic Ireland, of Galway, Ireland.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 46,202 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.