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

Recalled October 3, 2018 · FDA recall Z-3247-2018 · Shockwave Medical

Hazard

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

Units

612

Sold at

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

Description

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

Product

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

Manufacturer(s)

Shockwave Medical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →