Edwards Lifesciences recalls Fogarty Arterial Embolectomy Catheters with specific model numbers and lot numbers due to confirmed latex deterioration complaints. Affected units may have increased risk of allergic reactions or other complications.
“Edwards Lifesciences Fogarty Catheters Recall: Latex Deterioration Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59945-edwards-lifesciences-fogarty-catheters-recall-latex-deterioration-risk. Based on FDA recall #Z-0146-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0146-2023%22&limit=1).
The FDA announced on Oct. 6, 2022, that Edwards Lifesciences, LLC is recalling Fogarty Arterial Embolectomy Catheters due to confirmed latex deterioration complaints. The agency issued the recall under number Z-0146-2023.
How to tell if you have it
Brand: Edwards Lifesciences
Product: Fogarty Arterial Embolectomy Catheters and Fogarty Arterial Embolectomy Catheter with Stylet
The recall is due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. The record does not report specific incidents or injuries.
Context
GovInfoNow's records show Edwards Lifesciences, LLC has 25 other recalls on record since July 6, 2017. Recent brand recalls include the March 27, 2026 EVOQUE Tricuspid Delivery System labeling update and the May 14, 2025 Optisite Arterial Cannula recall for exposed wire risks. Other recent recalls of similar products include the Dec. 22, 2025 Medline ViewFlex Xtra ICE Catheters recall and the Dec. 22, 2025 Medline Livewire Steerable Catheters recall.
How to tell if you have this one
Check the model numbers: 120403FP, 120602FP, 120803FP, 120804FP, 120805FP, 120806FP, 120807FP. Also check the lot numbers listed in the recall notice for affected units.
Brand
Edwards Lifesciences
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
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.
Look for model numbers 120403FP, 120602FP, 120803FP, 120804FP, 120805FP, 120806FP, or 120807FP on the catheter packaging.
Check Lot Numbers
Verify if your catheter's lot number matches the list of affected lot numbers provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0146-2023 (October 6, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0146-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.