Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon Recalled by Shockwave Medical, Inc. Due to Catheter unable to maintain inflation pressure during treatment...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Shockwave Medical, Inc. directly.
Affected Products
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
Quantity: 612
Why Was This Recalled?
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
Where Was This Sold?
This product was distributed to 3 states: CO, TN, TX
About Shockwave Medical, Inc.
Shockwave Medical, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report