BEUDAMED
    FDA Enforcement Class II Terminated

    The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Shockwave S4, Peripheral Intravascular Lithotripsy Catheter, CE 0086, STERILE R, Manufacturer: Shockwave Medical, Inc. 48501 Warm Springs Blvd. Ste. 108, Fremont, CA 94539

    Recall: Z-3247-2018 · Reported October 3, 2018

    Enforcement

    Recall Number
    Z-3247-2018
    Event ID
    80865
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Shockwave Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 3, 2018
    Initiation Date
    July 18, 2018
    Classification Date
    September 25, 2018
    Termination Date
    January 22, 2020
    Address
    48501 Warm Springs Blvd Ste 108, Fremont, CA, 94539-7750, United States

    Description

    The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Shockwave S4, Peripheral Intravascular Lithotripsy Catheter, CE 0086, STERILE R, Manufacturer: Shockwave Medical, Inc. 48501 Warm Springs Blvd. Ste. 108, Fremont, CA 94539

    Reason

    Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).

    Code Info

    Catalog No. Part No. Size Lot # UDI (DI Portion Only) S4IVL2540 FG61163-2540 2.50x40mm P180222I M732S4IVL25400 P180327A P180410A P180503A S4IVL3040 FG61163-3040 3.00x40mm P180223A M732S4IVL30400 P180327B P180410B P180503B S4IVL3540 FG61163-3540 3.50x40mm P180223B M732S4IVL35400 P180327C P180410C P180503C S4IVL4040 FG61163-4040 4.00x40mm P180223C M732S4IVL40400 P180327D P180410D P180503D

    Distribution

    Domestic: CO, TN and TX Foreign: Austria, Germany and New Zealand

    Quantity

    612