Shockwave Medical The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced recall — FDA Z-3247-2018
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
Overview of recall records associated with Shockwave Medical, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
This page summarizes recall records in which the official source identifies Shockwave Medical, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.