BEUDAMED
    FDA Recall Open, Classified

    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter

    Recall: Z-2222-2026 · Initiated April 21, 2026

    Recall

    Recall Number
    Z-2222-2026
    Event Number
    98786
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DWF
    Status
    Open, Classified
    Root Cause
    Packaging process control
    Initiated
    April 21, 2026
    Posted
    May 20, 2026
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter

    Reason

    Certain lots of product have the potential for a sterile barrier breach.

    Action

    Medtronic Cardiac Surgery issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 4/21/2026 via UPS. The notice explained the issue, potential risk. and requested that the affected product be returned by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate return for credit or replacement product. Consignees were directed to share this notification with others in your organization as appropriate. If the product listed above has been forwarded to another facility, please notify the facility. For questions regarding this communication, consignees were asked contact their Medtronic representative.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.

    Quantity

    260 units