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Shockwave Medical Recalls

1 recall on record · October 3, 2018 to October 3, 2018 · Medical Devices

October 3, 2018Medical DevicesFDA

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

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

Shockwave Medical Recalls | RecallWatchUSA