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

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

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.