Pipeline Flex Embolization Device
Medical device recall Z-2402-2021. Published in FDA’s Enforcement Report on Sep 15, 2021.
- 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 Sep 15, 2021. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- 49 states named in where it went
- 16,169 total devices for all model/products 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?
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Pipeline Flex Embolization Device
16,169 total devices for all model/products, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product/REF/UDI: PED-250-10 PIPELINE FLEX 2.50MM X 10MM PED-250-10 00847536014343 Lot Numbers: A815698 A835648 A837027 A837028 A856681 A867213 A877526 A879720 A885865 A887304 A889034 A894160 A898559 A910394 A911797 A915537 Product/REF/UDI:…
Every code shown here, 1,999 characters
Product/REF/UDI: PED-250-10 PIPELINE FLEX 2.50MM X 10MM PED-250-10 00847536014343 Lot Numbers: A815698 A835648 A837027 A837028 A856681 A867213 A877526 A879720 A885865 A887304 A889034 A894160 A898559 A910394 A911797 A915537 Product/REF/UDI: PED-250-12 PIPELINE FLEX 2.50MM X 12MM PED-250-12 00847536014374 A813321 A819204 A822948 A848725 A876747 A879721 A887306 A887308 A887311 A887311 A887314 A887314 A894161 A894162 A894163 A904254 A908288 B005860 B017059 Product/REF/UDI: PED-250-14 PIPELINE FLEX 2.50MM X 14MM PED-250-14 00847536014404 Lot Numbers: A813323 A822948 A839880 A854063 A859756 A879723 A879724 A889035 A889037 A902102 A906073 A914143 A915539 Product/REF/UDI: PED-250-16 PIPELINE FLEX 2.50MM X 16MM PED-250-16 00847536014435 Lot Numbers: A822949 A829045 A843379 A882136 A887316 A889039 A894609 A909355 B005846 Product/REF/UDI: PED-250-18 PIPELINE FLEX 2.50MM X 18MM PED-250-18 00847536014466 Lot Numbers: A867848 A877526 A877527 A877532 A879725 A887317 A910395 B007408 Product/REF/UDI: PED-250-20 PIPELINE FLEX 2.50MM X 20MM PED-250-20 00847536014497 Lot Numbers: A867214 A877533 A885866 A885867 A887318 Product/REF/UDI: PED-275-10 PIPELINE FLEX 2.75MM X 10MM PED-275-10 00847536014527 Lot Numbers: A854607 A867215 A900753 A912447 B002744 Product/REF/UDI: PED-275-12 PIPELINE FLEX 2.75MM X 12MM PED-275-12 00847536014558 Lot Numbers: A822950 A864485 A866005 A873187 A873201 A885868 A885869 A906074 A909356 Product/REF/UDI: PED-275-14 PIPELINE FLEX 2.75MM X 14MM PED-275-14 00847536014589 Lot Numbers: A812097 A822951 A861761 A873187 A873201 A873204 A873205 A874035 A874035 A883589 A885870 A885871 A885872 A906076 A906725 Product/REF/UDI: PED-275-16 PIPELINE FLEX 2.75MM X 16MM PED-275-16 00847536014619 Lot Numbers: A813324 A877534 A883590 A894164 A894611 B005862 Product/REF/UDI: PED-275-18 PIPELINE FLEX 2.75MM X 18MM PED-275-18 00847536014640 Lot Numbers: A823540 A876748 A882137 A894613 Product/REF/UDI: PED-275-20 PIPELINE FLEX 2.75MM X 20MM PED-275-20 00847536014671 Lot Numbers:…
FDA’s list runs to 19,724 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.
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV O.U.S.: Argentina, Brazil Canada, Chile, Colombia, Ecuador, Mexico, Peru, Austria, Belgium, Canary Island, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Kazakhstan, Latvia, Macedonia, Netherlands, Norway, Poland, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Brunei Darussalam, Egypt, Israel, Jordan, Lebanon, Qatar, Saudi Arabia, Syrian Arab Republic, United Arab Emirates, South Africa, Tunisia, Reunion, China, Hong Kong, Macao, Singapore, Taiwan, Australia, New Zealand, Bangladesh, India, Pakistan, Indonesia, Malaysia, Thailand, Vietnam, Japan, and Republic of Korea.
The states and territories these words name
49 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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, 2021.
- FDA classified it on Sep 3, 2021.
- FDA’s Enforcement Report published it on Sep 15, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Micro Therapeutics Inc,, 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 19,724 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.