BEUDAMED
    FDA Enforcement Class II Ongoing

    Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit

    Recall: Z-1731-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1731-2020
    Event ID
    85227
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2020
    Initiation Date
    March 9, 2020
    Classification Date
    April 17, 2020
    Address
    100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States

    Description

    Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit

    Reason

    An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

    Code Info

    Lot Numbers: 24501748, 24506585, 24507390, 24507747, 24517205, 24517209, 24517211, 24526341, 24576484, 24576569, 24577900, 24579133, 24580102, 24583255, 24585905, 24586401, 24616721, 24617337, 24618334, 24724936, 24732742, 24737184, 24739802, 24790717, 24805720, 24860825, 24868932

    Distribution

    Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

    Quantity

    5,565