X-Celerator Hydrophilic Exchange Guidewire
Medical device recall Z-0310-2017. Published in FDA’s Enforcement Report on Nov 16, 2016.
- FDA Class I
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 Nov 16, 2016. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 10,516 units 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-300V09 103-0601-300V11 103-0602-300V10 103-0601-350 103-0602-350 103-0601-350V01 103-0602-350V01 103-0601-350V06 103-0602-350V02
10,516 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
9530849 9709603 9797735 A002136 A043280 A123449 A183571 9530851 9743324 9802698 A002460 A043281 A123450 A185838 9531882 9743328 9802700 A002610 A043969 A123452 A185841 9567732 9746399 9848318 A004560 A044251 A134837 A194324 9585211 9746403…
Every code shown here, 1,724 characters
9530849 9709603 9797735 A002136 A043280 A123449 A183571 9530851 9743324 9802698 A002460 A043281 A123450 A185838 9531882 9743328 9802700 A002610 A043969 A123452 A185841 9567732 9746399 9848318 A004560 A044251 A134837 A194324 9585211 9746403 9882269 A004561 A044252 A136164 A194327 9585247 9750614 9931088 A005008 A097470 A136165 A195347 9585249 9750615 9931089 A005011 A097472 A142394 A200386 9585282 9750618 9931093 A005477 A097473 A142395 A200387 9585283 9750619 9979485 A005478 A097474 A145004 A202560 9594629 9750621 9979495 A006080 A097475 A136161 A202563 9601922 9750624 9979497 A006171 A097476 A145006 A211246 9601924 9751548 9979498 A006176 A097477 A145149 A211248 9612762 9767048 9979500 A006182 A114384 A145150 A217138 9612763 9794407 201401398X A006887 A114385 A145152 A217141 9628372 9794409 201601079E A008199 A114389 A145153 A217142 9641711 9794795 201602502E A008201 A114391 A150759 A221040 9643550 9794924 201603429E A014137 A114393 A150762 A221041 9660868 9794925 201603430E A014297 A114543 A150764 A221042 9666144 9795119 201605381E A014819 A114545 A151577 A221043 9666146 9795120 201605382E A014821 A114546 A152854 A237364 9666148 9795516 201605383E A014825 A115726 A152856 A237366 9666835 9795517 201605384E A019031 A116267 A159822 A237368 9667132 9796816 201606174E A019337 A116270 A159826 A243986 9690683 9796817 201606178E A035856 A116271 A165319 A243987 9690686 9796817 201606179E A035858 A116272 A165320 A243988 9690687 9796818 201606180E A037439 A116274 A165321 A247255 9701004 9797467 201606297E A040174 A123439 A183549 A247256 9702147 9797469 201606298E A040176 A123440 A183550 A247259 9706211 9797470 A002129 A040177 A123442 A183561 A247270 9709599 9797734 A002131 A040222 A123445 A183563 A258089
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) and Internationally to Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
These words name no state.
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 Oct 5, 2016.
- FDA classified it on Nov 9, 2016.
- FDA’s Enforcement Report published it on Nov 16, 2016.
- FDA terminated it on Oct 11, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Micro Therapeutics Inc, Dba Ev3 Neurovascular, of Irvine, CA.
- 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.”
- 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.