ev3 Pipeline Flex Embolization Device
Medical device recall Z-1527-2020. 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
- 1050 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. For neurological endovascular use.
1050, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots: A920066 A920068 A920069 A920070 A920071 A920072 A920073 A920074 A920075 A920076 A920078 A920079 A921354 A921355 A921356 A921357 A921358 A921359 A921360 A921361 A921362 A921363 A922016 A922017 A922018 A922020 A922021 A922022 A922480…
Every code shown here, 1,998 characters
Lots: A920066 A920068 A920069 A920070 A920071 A920072 A920073 A920074 A920075 A920076 A920078 A920079 A921354 A921355 A921356 A921357 A921358 A921359 A921360 A921361 A921362 A921363 A922016 A922017 A922018 A922020 A922021 A922022 A922480 A922481 A922483 A922484 A922571 A922572 A922575 A923951 A923956 A923959 A923960 A923963 A923967 A923968 A923969 A924193 A924194 A924197 A924198 A924199 A924638 A924640 A924641 A924642 A924643 A924644 A924645 A924646 A924647 A924648 A924650 A927827 A927828 A927829 A927830 A927831 A927832 A927833 A927834 A927835 A927836 A927837 A927838 A927839 A927840 A927841 A927842 A927843 A927844 A927845 A927847 A927848 A929704 A929705 A929706 A929707 A929708 A929710 A929711 A929713 A929714 A929716 A929717 A929893 A929894 A929896 A929897 A929898 A929901 A929902 A929903 A929904 A929906 A929907 A932604 A932605 A932607 A932609 A932610 A932611 A932612 A932613 A933706 A933707 A933709 A933710 A933781 A933782 A933783 A933784 A933785 A933786 A933787 A933788 A933789 A934499 A934500 A934503 A934504 A934505 A934506 A935182 A935184 A937237 A937238 A937239 A937240 A937241 A937645 A937646 A937647 A937648 A937649 A937650 A937651 A937652 A937653 A937654 A938289 A938290 A938291 A938293 A939611 A941306 A941307 A941308 A941309 A941310 A942157 A942159 A942160 A942161 A942162 A942163 A942164 A942165 A942166 A944241 A944242 A944244 A944245 A944246 A944247 A944249 A944250 A944251 A944253 A944254 A944255 A944256 A944257 A945204 A945205 A945438 A945441 A945445 A945447 A945450 A945451 A945452 A945454 A945455 A946808 A946811 A946813 A946815 A946816 A946817 A947150 A947151 A947152 A947153 A947154 A947155 A947396 A947397 A947398 A947399 A947400 A947401 A947402 A947403 A947405 A947407 A947408 A948123 A948124 A948125 A948126 A948127 A948128 A948129 A948130 A948131 A949486 A949487 A949488 A949489 A949490 A949491 A949492 A949493 A949494 A949495 A949496 A949497 A950324 A950329 A950332 A950333 A950335 A950337 A950341 A950344 A950346 A950753 A950754 A950945 A950946 A950947 A952499…
FDA’s list runs to 2,541 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 2,541 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.