BEUDAMED
    FDA Enforcement Class II Ongoing

    Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

    Recall: Z-2128-2023 · Reported July 19, 2023

    Enforcement

    Recall Number
    Z-2128-2023
    Event ID
    92521
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abiomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 19, 2023
    Initiation Date
    May 26, 2023
    Classification Date
    July 11, 2023
    Address
    24 Cherry Hill Dr, N/A, Danvers, MA, 01923-2575, United States

    Description

    Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

    Reason

    There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.

    Code Info

    UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590

    Distribution

    US Nationwide distribution in the states of MN, NJ, TN.

    Quantity

    37 units