BEUDAMED
    FDA Enforcement Class II Ongoing

    DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only

    Recall: Z-2504-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2504-2021
    Event ID
    88549
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Perfusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 29, 2021
    Initiation Date
    August 24, 2021
    Classification Date
    September 22, 2021
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088, United States

    Description

    DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only

    Reason

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

    Code Info

    Model/Reference Number 12116, Lot Number (GTIN Number): 2018080039 (20643169086719), 2018091020 (20643169086719), 2018100911 (20643169086719), 2018111023 (20643169086719), 2018111419 (20643169086719), 2019120925 (20643169086719), 2018080039 (00673978462943), 2018091020 (00673978462943), 2018100911 (00673978462943), 2018111023 (00673978462943), 2018111419 (00673978462943), 2018120581 (20643169086719), 2018120581 (00673978462943), 2018120582 (20643169086719), 2018120582 (00673978462943), 2018121084 (20643169086719), 2018121084 (00673978462943), 2019010456 (20643169086719), 2019010456 (00673978462943), 2019010764 (20643169086719), 2019010764 (00673978462943), 2019020136 (20643169086719), 2019020136 (00673978462943), 2019020368 (20643169086719), 2019020368 (00673978462943), 2019020758 (20643169086719), 2019020758 (00673978462943), 2019030720 (20643169086719), 2019030720 (00673978462943), 2019031167 (20643169086719), 2019031167 (00673978462943), 2019040262 (20643169086719), 2019040262 (00673978462943), 2019040472 (20643169086719), 2019040472 (00673978462943), 2019040473 (20643169086719), 2019040473 (00673978462943), 2019041189 (20643169086719), 2019041189 (00673978462943), 2019050576 (20643169086719), 2019050576 (00673978462943), 2019060984 (20643169086719), 2019060984 (00673978462943), 2019071114 (20643169086719), 2019071114 (00673978462943), 2019090071 (20643169086719), 2019090071 (00673978462943), 2019091024 (20643169086719), 2019091024 (00673978462943), 2019100417 (20643169086719), 2019100417 (00673978462943), 2019101444 (20643169086719), 2019101444 (00673978462943), 2019111049 (20643169086719), 2019111049 (00673978462943), 2019120925 (00673978462943), 2020010368 (20643169086719), 2020010368 (00673978462943), 2020010445 (20643169086719), 2020010445 (00673978462943), 2020011619 (20643169086719), 2020011619 (00673978462943), 2020011620 (20643169086719), 2020011620 (00673978462943), 2020030064 (20643169086719), 2020030064 (00673978462943), 2020030848 (20643169086719), 2020030848 (00673978462943), 2020030849 (20643169086719), 2020030849 (00673978462943), 2020041429 (20643169086719), 2020041429 (00673978462943), 2020041430 (20643169086719), 2020041430 (00673978462943), 2020050078 (20643169086719), 2020050078 (00673978462943), 2020060672 (20643169086719), 2020060672 (00673978462943), 2020120078 (20643169086719), 2020120078 (00673978462943), 2020120619 (20643169086719), 2020120619 (00673978462943), 2021010032 (20643169086719), 2021010032 (00673978462943), 2021010552 (20643169086719), 2021010552 (00673978462943), 2021011167 (20643169086719), 2021011167 (00673978462943), 2021020486 (20643169086719), 2021020486 (00673978462943), 2021020985 (20643169086719), 2021020985 (00673978462943), 2018080040 (20643169086719), 2018090064 (20643169086719), 2018090434 (20643169086719), 2018091019 (20643169086719), 2018100118 (20643169086719), 2018100522 (20643169086719), 2018101295 (20643169086719), 2018101296 (20643169086719), 2018111418 (20643169086719), 2018111420 (20643169086719), 2018121083 (20643169086719), 201901C047 (20643169086719), 201901C048 (20643169086719), 201901C049 (20643169086719), 2019020759 (20643169086719), 201902C156 (20643169086719), 2019051126 (20643169086719), 201905C012 (20643169086719), 2019060218 (20643169086719), 2019060423 (20643169086719), 2019060686 (20643169086719), 201906C175 (20643169086719), 2019070713 (20643169086719), 2019081001 (20643169086719), 2019081291 (20643169086719), 2019091156 (20643169086719), 2019091157 (20643169086719), 2019100416 (20643169086719), 2019100731 (20643169086719), 2019101094 (20643169086719), 2019101445 (20643169086719), 2019110083 (20643169086719), 2019120089 (20643169086719), 2019120926 (20643169086719), 2020010369 (20643169086719), 2020020093 (20643169086719), 2020020470 (20643169086719), 2020020471 (20643169086719), 2020020763 (20643169086719), 2020030850 (20643169086719), 2020031186 (20643169086719), 2020040402 (20643169086719), 2020040762 (20643169086719), 2020050352 (20643169086719), 2020050699 (20643169086719), 2020050918 (20643169086719), 2020060963 (20643169086719), 2020070653 (20643169086719), 2020070654 (20643169086719), 2020070967 (20643169086719), 2020070968 (20643169086719), 2020071272 (20643169086719), 2020080074 (20643169086719), 2020080408 (20643169086719), 2020080409 (20643169086719), 2020080715 (20643169086719), 2020081032 (20643169086719), 2020081033 (20643169086719), 2020090631 (20643169086719), 2020100785 (20643169086719), 2020101109 (20643169086719), 2020110380 (20643169086719), 202011C197 (20643169086719), 202011C243 (20643169086719), 202011C244 (20643169086719), 2021010033 (20643169086719), 2021010034 (20643169086719), 2021011166 (20643169086719), 2021020487 (20643169086719), 2021020798 (20643169086719), 2021020986 (20643169086719), 2021020987 (20643169086719), 202102C091 (20643169086719), 202102C092 (20643169086719), 202102C093 (20643169086719), 2021030719 (20643169086719), 2021030720 (20643169086719), 2021031307 (20643169086719), 2021040872 (20643169086719), 2021041147 (20643169086719), 2021041148 (20643169086719), 2021050634 (20643169086719), 202105C140 (20643169086719), 202105C141 (20643169086719), 202105C142 (20643169086719), 202106C025 (20643169086719). Expiration date range: 09/30/2020 - 05/19/2024

    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

    51,494 units