FDAJuly 18, 2018device
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 Lithot...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
What to do
FDA enforcement status: Terminated
Brands named
shockwave medicalshockwave
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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