Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA)…
Medical device recall Z-3137-2017. 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
- 105,633 (OUS) 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?
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
105,633 (OUS), 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 SLC2525X 00643169680234 212610381 SLC3520X 00643169680449 212610395 SLC1520X 00643169680043 212610391 SLC2015X 00643169680081 212610384 SLC2020X 00643169680098 212621132 SLC2515X 00643169680210 212610388…
Every code shown here, 1,987 characters
Product Number / CFN GTIN Lot SLC2525X 00643169680234 212610381 SLC3520X 00643169680449 212610395 SLC1520X 00643169680043 212610391 SLC2015X 00643169680081 212610384 SLC2020X 00643169680098 212621132 SLC2515X 00643169680210 212610388 SLC2520X 00643169680227 212621130 SLC4015X 00643169680531 212610378 SLC27520X 00643169680289 212621127 SLC27515X 00643169680272 212621128 SLC3515X 00643169680432 212621129 SLC3020X 00643169680340 212663250 SLC22510X 00643169680135 212671839 SLC3010X 00643169680319 212663249 SLC22506X 00643169680128 212671834 SLC2506X 00643169680180 212671836 SLC2025X 00643169680104 212671880 SLC37515X 00643169680487 212671833 SLC32515X 00643169680388 212671838 SLC4010X 00643169680517 212671837 SLC22520X 00643169680166 212663251 SLC3006X 00643169680302 212671835 SLC2020X 00643169680098 212691165 SLC2512X 00643169680203 212691118 SLC2515X 00643169680210 212691164 SLC2015X 00643169680081 212691160 SLC22512X 00643169680142 212691163 SLC2025X 00643169680104 212691167 SLC2020X 00643169680098 212702017 SLC2530X 00643169680241 212691173 SLC1512X 00643169680029 212691119 SLC2515X 00643169680210 212702018 SLC2015X 00643169680081 212702463 SLC2012X 00643169680074 212710905 SLC2030X 00643169680111 212710910 SLC2510X 00643169680197 212710908 SLC2512X 00643169680203 212702020 SLC2520X 00643169680227 212702019 SLC22520X 00643169680166 212702021 SLC2015X 00643169680081 212702016 SLC3030X 00643169680364 212691171 SLC2020X 00643169680098 212702465 SLC2012X 00643169680074 212709027 SLC2015X 00643169680081 212709026 SLC1520X 00643169680043 212702462 SLC2525X 00643169680234 212691168 SLC22525X 00643169680173 212691166 SLC2012X 00643169680074 212709723 SLC1512X 00643169680029 212702464 SLC2515X 00643169680210 212709726 SLC2512X 00643169680203 212709724 SLC3020X 00643169680340 212710906 SLC1510X 00643169680012 212710907 SLC1515X 00643169680036 212709725 SLC1520X 00643169680043 212709025 SLC4015X 00643169680531 212691162 SLC3512X 00643169680425 212710909 SLC4020X…
FDA’s list runs to 15,171 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 15,171 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
-
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.