BEUDAMED
    FDA Recall Open, Classified

    Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP

    Recall: Z-0147-2023 · Initiated October 6, 2022

    Recall

    Recall Number
    Z-0147-2023
    Event Number
    90905
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    2015691
    Product Code
    DXE
    Status
    Open, Classified
    Root Cause
    Packaging
    Initiated
    October 6, 2022
    Posted
    October 28, 2022
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP

    Reason

    Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

    Action

    On 10/06/2022, Edwards Lifesciences sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx 2nd Day to customer informing them that certain lots of Fogarty arterial embolectomy catheters and Fogarty biliary balloon probes are exhibiting latex deterioration in the balloon. It was determined that storage of these devices in the same room room as high energy ionizing radiation sources which can act as an ozone generator to the immediate environment, can accelerate latex deterioration and subsequent balloon failures. Advice on action to be taken by users: It is requested that they do not store Fogarty arterial embolectomy catheters and Fogarty biliary balloon probes in rooms with high energy ionizing radiation sources that could generate ozone (e.g. Fluoroscopy machines, X-ray machines, UV lights, HVAC sanitation equipment, etc). Post the attached notification as a constant reminder to their staff of the issue. - If they have devices that have been exposed to the equipment described above, please return the affected inventory with the model and lot number referenced above. - If they have devices that have not been exposed to the equipment above (e.g. stored away from high energy ionizing radiation source), they may continue to use the devices per the IFU. Review their inventory and quarantine any exposed product until prepared for return to Edwards Lifesciences. Follow the instructions included in the enclosed customer acknowledgement form and return within 5 days of receipt of this notification. Edwards Customer Service 1-800-424-3278 from 5:00 a.m. to 4:30 p.m. PST.

    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.

    Quantity

    26,560 units