Fogarty Arterial Embolectomy Catheters
Medical device recall Z-0146-2023. Published in FDA’s Enforcement Report on Nov 9, 2022.
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 9, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 52 states named
- 715,620 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
715,620 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Fogarty Arterial 120403FP Embolectomy Catheters Model Number / UDI-DI Code: 120602FP / 00690103205206 Lot Numbers: 63325817 63412990 64049166 64052416 64320468 64311217 64286041 64075556 64085285 64124889 64180619 63914203 63967960…
Every code shown here, 1,999 characters
Fogarty Arterial 120403FP Embolectomy Catheters Model Number / UDI-DI Code: 120602FP / 00690103205206 Lot Numbers: 63325817 63412990 64049166 64052416 64320468 64311217 64286041 64075556 64085285 64124889 64180619 63914203 63967960 63266275 63281593 63449645 63560630 63612077 63626926 63738860 63735762 63750304 63772968 63724845 63914201 63892007 63967950 63990050 64027881 64036551 64052415 64063487 64124888 64173669 64180620 64180548 64332505 64344742 63907174 64099010 64099008 63420190 63435603 63476159 63511721 63600508 63611742 63669399 63750303 63735818 63850952 63907175 63944429 63984736 63944467 63907167 64014108 63995701 64036698 64075555 64180549 64173668 64110676 64205522 64220842 64252735 64231811 64231810 64264792 64274428 64297806 64297810 64321021 64321020 63281591 63375216 63420189 63464807 63501933 63560629 63634785 63612076 63914359 64193163 64266393 64239056 63375217 64059266 64252737 63735761 63412989 63600507 63633312 63990049 64193162 64205539 64383524 64394451 63611743 63352974 63386855 63340743 63349810 63432009 63449644 63476158 63435604 63487678 63464806 63513249 63612073 63612074 63560631 63669400 63612075 63661028 63670579 63670029 63670031 63712780 63687299 63712779 63670028 63776322 63797464 63892006 63850950 63856376 63883760 63883761 63944427 63954394 63990047 63990048 64025093 64063485 64099009 64180550 64383526 64243759 64205521 64273885 64239057 64276520 64252736 64274714 64297805 64264793 64286039 64343086 64354938 64368268 64368267 64085286 64344743 64354939 120403FP / 00690103205084 Lot Numbers: 63281594 63420192 63293457 63292302 63435605 63227617 63266276 63851020 64180623 64063399 64180621 64173655 64349486 64274431 63735809 63600513 63611735 63611730 63612145 63612148 63612150 63750306 63851019 63967943 64049155 64085389 64205542 63412996 63646477 63626918 63851013 64075580 64286055 63449646 63523069 63801880 64220844 63525902 63669388 63243860 63292299 63243604 63508558 63511555 63611731 63600510 63611734 63554739 63600511…
FDA’s list runs to 12,003 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 - U.S. Nationwide distribution including in the states of 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, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bulgaria, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guam, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Malta, Mauritius, Morocco, Netherlands, Nicaragua, Northern Ireland, Oman, Panama, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates (UAE), United Kingdom.
The states and territories these words name
52 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
- Montana
- 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
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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?
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 Oct 6, 2022.
- FDA classified it on Oct 28, 2022.
- FDA’s Enforcement Report published it on Nov 9, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Edwards Lifesciences, LLC, 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 12,003 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
-
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.