BEUDAMED
    FDA Enforcement Class I Ongoing

    Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323

    Recall: Z-2281-2023 · Reported August 9, 2023

    Enforcement

    Recall Number
    Z-2281-2023
    Event ID
    92411
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abiomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 9, 2023
    Initiation Date
    June 29, 2023
    Classification Date
    August 3, 2023
    Address
    22 &, 24 Cherry Hill Dr, Danvers, MA, 01923-2575, United States

    Description

    Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323

    Reason

    A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis

    Code Info

    UDI-DI: 00813502012811; Serial Numbers: 409541 409542 409544 411379 416645 416646 416647 416649 418933 418939 418940 419489 421953 421955 422974 422978 423999 425596 428726 428730 429616 429617 429623 429646 429648 429649 429650 429651 429652 429654 430363 430365 430366 430367 430923 430929 430931 431099 431106 431532 431535 431844 431846 431847 431848 431850 431868 431869 431870 432394 432395 432396 432397 432398 432400 432401 432402 432643 432644 432645 432648 432651 433755 433756 434540

    Distribution

    US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA, MI, MO, NC, NJ, NY, OH, OR, SC, TX, and WI.

    Quantity

    166 units