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Shockwave Medical IVL Generator and Connector Cable

Shockwave Medical, Inc. · Model IVLGCCDC · UDI-DI 00195451000461

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510(k) clearances

243

Adverse events (19 deaths)

Recalls

Facilities

Description

The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic arteries.

Recalls

Date	Firm	Reason
2018-07-18	Shockwave Medical, Inc.	Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.