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Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter

Shockwave Medical, Inc. · Model M5IVL6060 · UDI-DI 00195451000171

PPN Prescription

510(k) clearances

243

Adverse events (19 deaths)

Recalls

Facilities

Description

The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).

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.