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Edwards Lifesciences, LLC recalls Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Recalled November 9, 2022 · FDA recall Z-0147-2023 · Edwards Lifesciences
Hazard
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. · FDA Class II
Units
26,560 units
Sold at
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.
Description
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Product
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →