BEUDAMED
    FDA Recall Open, Classified

    DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only

    Recall: Z-2505-2021 · Initiated August 24, 2021

    Recall

    Recall Number
    Z-2505-2021
    Event Number
    88549
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DRA
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 24, 2021
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only

    Reason

    Potential for a wire protrusion through the left heart vent catheter tip

    Action

    On about 08/24/2021, Medtronic notified customers via 2-day tracked mail letter titled, "URGENT MEDICAL DEVICE RECALL DLP Left Heart Vent Catheters." The letter instructed customers identify and quarantine all affected DLP Left heart Vent Catheters, return all unused affected product in inventory to Medtronic by contacting Medtronic Customer Service at 1-800-854-3570 and to contact your local Medtronic Representative can assist you in the return of this product, and complete and return the provided Customer Confirmation Form and email to [email protected]. Additional instructions included to notify anyone within your organization that should be aware or to any organization where the potentially affected devices have been transferred.

    Distribution

    Nationwide distribution to AL, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI. International distribution to Albania, Algeria, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, Colombia, Costa Rica, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Norway, Pakistan, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Viet Nam, Yemen.

    Quantity

    48,672 units