BEUDAMED
    FDA Recall Open, Classified

    EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only

    Recall: Z-2038-2024 · Initiated April 25, 2024

    Recall

    Recall Number
    Z-2038-2024
    Event Number
    94541
    Firm
    Covidien, LLC
    FEI Number
    3004904811
    Product Code
    PID
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 25, 2024
    Posted
    June 7, 2024
    Address
    3062 Bunker Hill Ln, Santa Clara, CA, 95054-1105

    Description

    EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only

    Reason

    Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.

    Action

    On April 25, 2024, Medtronic issued a "Urgent: Medical Device Recall" Notification. Medtronic ask consignees to take the following actions: 1. Immediately identify and quarantine all unused EsoflipTM dilation catheter 30mm Model # ES-330 from the affected lot numbers. 2. Return all unused affected product(s) in your inventory to: Medtronic Attn: Field Returns Dept. 195 McDermott Road North Haven, CT 06473 USA 3. Credit for returned catheters that are part of this recall will be applied upon receipt. 4. Please complete and return the enclosed Customer Confirmation Form, even if you have no product to return. 5. Product purchased directly from Medtronic, please contact 1-800-448-3644 (option 2 followed by option 2 again) for Return Goods Authorization (RGA). Your local Medtronic Representative can assist you as necessary in initiating the return of this product. 6. If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. 7. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 8. Please transfer this notice to other organizations on which this action has an impact. 9. Please maintain a copy of this notice in your records.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Canada, Denmark, Germany, Ireland, Italy, Kuwait, New Zealand, Norway, Portugal, Qatar, South Africa, Switzerland, United Arab Emirates.