Fogarty Biliary Balloon Probes
Medical device recall Z-0147-2023. 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
- 26,560 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 Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
26,560 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Fogarty Biliary Balloon Probes Model Number / UDI-DI Codes: 410235FP / 00690103205114 Lot Numbers: 63292039 63374470 63412896 64180571 63750242 63872214 64049156 63996739 64063636 64180488 64205434 64220702 64285955 64332465 63301401…
Every code shown here, 1,759 characters
Fogarty Biliary Balloon Probes Model Number / UDI-DI Codes: 410235FP / 00690103205114 Lot Numbers: 63292039 63374470 63412896 64180571 63750242 63872214 64049156 63996739 64063636 64180488 64205434 64220702 64285955 64332465 63301401 63676960 63669366 63420116 64285954 64297660 63484862 63669362 63996741 64014018 64231686 63797438 63488864 63435505 63475892 63560673 63544106 63600417 63611703 63623913 63633116 63669365 63669367 63611693 63687302 63724846 63712314 63734561 63738744 63850841 63755535 63772701 63872208 63913697 63891308 63954283 63914241 63942913 63995664 64052315 64052316 64085209 64085211 64098951 64110568 64124822 64193089 64238925 64264720 64252665 64274393 64357529 64347351 64354870 64393877 410405FP / 00690103205138 Lot Numbers: 63226302 63451847 64238928 63374472 63412898 63623906 63623905 63850845 63996749 64014019 64036646 64025083 64036645 64075497 64098950 64098952 64311169 63567220 63996747 63755536 63420118 63669363 64367703 63523275 63560687 64432720 63435506 63501828 63676958 63669905 63734588 63738745 63891310 63967946 64124830 64264722 64285972 64332467 64383520 410236FP / 00690103205121 Lot Numbers: 63292038 63420115 63435504 64205435 63850842 63226301 63464730 63501827 63669361 63750241 63942926 64025081 64049154 64110566 64124823 64264721 64344497 64354872 64357758 63850844 63954282 64075493 63872209 63412897 63623904 63633115 63734582 64014017 64193091 63687303 63850843 63669368 63967945 63734583 63996744 63995665 64285970 6363315 63420117 63560678 63488865 63523271 63611692 63623920 63669360 63676959 63755534 63772703 63891309 63914245 63913696 63942919 63967941 64036643 64085210 64098949 64180572 64220703 64231971 64238927 64274394 64311168 64297662 64320970 64344498 64367702 64393879 64383519
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.”
- 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.