Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device…
Medical device recall Z-0309-2017. 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
- 66,429 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?
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
66,429 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
9946730 9960999 9965968 9974493 A004327 A011297 A016502 A024591 9952156 9961016 9965970 9975117 A004329 A011515 A016504 A024594 9952519 9961297 9965980 9975118 A004435 A011522 A016507 A024893 9952892 9961308 9965983 9976018 A004436 A011731…
Every code shown here, 2,000 characters
9946730 9960999 9965968 9974493 A004327 A011297 A016502 A024591 9952156 9961016 9965970 9975117 A004329 A011515 A016504 A024594 9952519 9961297 9965980 9975118 A004435 A011522 A016507 A024893 9952892 9961308 9965983 9976018 A004436 A011731 A016510 A024894 9953171 9961313 9965984 9976024 A004437 A011735 A016632 A024896 9953177 9963245 9966022 9976049 A004535 A011818 A017149 A025130 9953699 9963247 9966200 9976052 A004537 A011845 A017150 A025857 9953892 9963249 9966203 9976055 A004542 A011972 A017154 A025862 9955091 9963378 9966205 9978598 A004543 A012088 A018239 A026331 9955406 9963380 9966550 A000215 A004544 A012341 A018301 A026336 9955408 9963382 9966562 A000219 A004614 A012591 A018307 A026337 9955530 9963386 9966563 A000220 A004616 A012691 A018310 A026375 9955561 9963622 9966674 A000369 A005866 A012738 A018721 A027449 9955726 9963627 9966674 A000453 A005870 A012743 A018722 A027805 9955727 9963633 9966676 A002304 A005980 A012755 A018741 A027862 9955845 9963851 9966934 A002305 A006045 A013058 A018885 A027922 9956028 9964145 9966945 A002307 A006222 A013211 A019293 A028081 9956396 9964148 9966946 A002404 A006225 A013685 A019401 A028468 9956460 9964157 9971999 A002406 A006229 A013686 A019539 A028566 9957242 9964161 9972000 A002408 A006237 A013688 A019550 A028760 9957512 9964259 9972002 A002595 A006829 A013689 A019567 A028777 9957684 9964494 9972610 A002606 A006831 A013796 A019573 A028780 9957685 9964496 9972613 A002616 A006834 A013969 A019834 A028787 9957927 9964498 9972719 A002898 A007148 A014018 A019912 A029143 9957947 9964756 9972720 A003029 A007150 A014061 A020026 A029145 9957949 9964810 9973291 A003038 A007304 A014063 A020056 A029146 9958187 9964826 9973322 A003039 A007344 A014351 A020244 A029318 9958345 9965055 9973329 A003044 A007345 A014352 A020313 A029460 9958346 9965062 9973567 A003164 A007349 A014359 A020315 A029508 9958393 9965067 9973570 A003291 A007354 A014450 A020457 A029610 9958740 9965070 9973597 A003296 A007462 A014753 A020464 A029613 9958741 9965483…
FDA’s list runs to 14,575 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) 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.”
- FDA’s list of codes runs to 14,575 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.