FDA-Device2022-11-09Class II
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Edwards Lifesciences, LLC
Hazard
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Sold states
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.
Affected count
26,560 units
Manufactured in
1 Edwards Way, N/A, Irvine, CA, United States
Products
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0147-2023Don't want to check this manually?
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