BEUDAMED
    FDA Enforcement Class II Ongoing

    C315-HIS Delivery Catheter

    Recall: Z-0173-2022 · Reported November 3, 2021

    Enforcement

    Recall Number
    Z-0173-2022
    Event ID
    88688
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 3, 2021
    Initiation Date
    September 9, 2021
    Classification Date
    October 22, 2021
    Address
    8200 Coral Sea St Ne, N/A, Mounds View, MN, 55112-4391, United States

    Description

    C315-HIS Delivery Catheter

    Reason

    Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.

    Code Info

    GTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 10568899), and C315HIS04 (Serial Number/Lot Number: 10568900)

    Distribution

    Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.

    Quantity

    591 units