BEUDAMED
    FDA Recall 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 · Initiated July 18, 2018

    Recall

    Recall Number
    Z-3247-2018
    Event Number
    80865
    Firm
    Shockwave Medical, Inc.
    FEI Number
    3015053858
    Product Code
    PPN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 18, 2018
    Terminated
    January 22, 2020
    Address
    48501 Warm Springs Blvd, Ste 108, Fremont, CA, 94539-7750

    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).

    Action

    On 7/19/2018, the firm sent an Urgent Medical Device Recall Notice to distribution chain/consignees via e-mail informing them that, in some cases, the S4 Peripheral IVL Catheter is not performing as intended. We have seen instances of leaks in the balloon which prevent the balloon from staying inflated at 4 atm for the full course of lithotripsy application. There have been no reports of adverse clinical events related to this issue. This issue does not impact patients who were previously treated with the S4 device. Customers were instructed to discontinue use of all S4 IVL products listed in the recall and place it into quarantine until a Shockwave representative was able to arrange for the S4 IVL product to be returned to Shockwave Medical. The Shockwave representative retrieving the product from the customer is to complete the Acknowledgement and Receipt Form. Recall Contact Nora Hadding Vice President, Quality and Regulatory Affairs Email: [email protected] Phone: 510-279-4262 Monday through Friday, 8:00 AM to 4:30 PM Pacific time.

    Distribution

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

    Quantity

    612