ev3 Pipeline Flex Embolization Device with Shield Technology
Medical device recall Z-1528-2020. Published in FDA’s Enforcement Report on Apr 1, 2020.
- 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 Apr 1, 2020. 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
- 762 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?
Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
762, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots: A918616 A918617 A918618 A918619 A918620 A918621 A918622 A918623 A918624 A918625 A918626 A918628 A918665 A918667 A918668 A920902 A922597 A922598 A922599 A922600 A922601 A922687 A922688 A922690 A922691 A922692 A922693 A922694 A922695…
Every code shown here, 1,998 characters
Lots: A918616 A918617 A918618 A918619 A918620 A918621 A918622 A918623 A918624 A918625 A918626 A918628 A918665 A918667 A918668 A920902 A922597 A922598 A922599 A922600 A922601 A922687 A922688 A922690 A922691 A922692 A922693 A922694 A922695 A922697 A922698 A922699 A925289 A925290 A925291 A925292 A925293 A925295 A925296 A925297 A925298 A925299 A925300 A925913 A925914 A925915 A925917 A925918 A925920 A925923 A925926 A925928 A925929 A925930 A925931 A926530 A926531 A926532 A926533 A926536 A926537 A926538 A926625 A926626 A926627 A926628 A926629 A927960 A927961 A927962 A931450 A931451 A931452 A931453 A931454 A931455 A931456 A931458 A931459 A931460 A934805 A934806 A934807 A934808 A934809 A935480 A935481 A935482 A935483 A935484 A935486 A935487 A935900 A935901 A935902 A935903 A935904 A935912 A935913 A935914 A935916 A935917 A936513 A936514 A936515 A936516 A936517 A936518 A936519 A936520 A936522 A936523 A936524 A937232 A937233 A937234 A937235 A937236 A937242 A937655 A938294 A938295 A938296 A938297 A938298 A938299 A938301 A939100 A939101 A939103 A939104 A939137 A939138 A939139 A939140 A939142 A939143 A939144 A939145 A939146 A939148 A939151 A939154 A939612 A939613 A939614 A939615 A939616 A939617 A939618 A939619 A939620 A939621 A939622 A939623 A939624 A939625 A939626 A939627 A939628 A939629 A939630 A939632 A941401 A941403 A941404 A941405 A941406 A941407 A941409 A941410 A941411 A941415 A941417 A942167 A942168 A943052 A943053 A943054 A943056 A943219 A943220 A943222 A943321 A943322 A943324 A943326 A943672 A943674 A943676 A943677 A943678 A943680 A943682 A943683 A943684 A943686 A945206 A945207 A945208 A945209 A945210 A946108 A946109 A946110 A946591 A946592 A948115 A948116 A948117 A948118 A948119 A948120 A948121 A948122 A950755 A950756 A950757 A950758 A950759 A950760 A950941 A950942 A950943 A950944 A952144 A952145 A952146 A952147 A952148 A952149 A952150 A952153 A952154 A952155 A952156 A952157 A952483 A952484 A952485 A952486 A952487 A952488 A952489 A952490 A952491 A952497 A952498 A952684…
FDA’s list runs to 2,589 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, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Jordan, Kazakhstan, Korea, Lebanon, Mexico, Netherlands, Norway, Paraguay, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam
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 Feb 14, 2020.
- FDA classified it on Mar 25, 2020.
- FDA’s Enforcement Report published it on Apr 1, 2020.
- FDA terminated it on Jun 12, 2024.
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 2,589 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.