Shockwave Medical, Inc. recalls The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified…

Recall date

July 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3247-2018

FDA classification

Class II

Brand / firm

Shockwave Medical, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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