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Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter

Shockwave Medical, Inc. · Model S4IVLK4040 · UDI-DI 00195451000348

OEZPPNJAA Prescription
0
510(k) clearances
1,350
Adverse events (17 deaths)
230
Recalls
59
Facilities

Description

The Shockwave S4 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 distal catheter and balloon are hydrophilic coated to increase lubricity. 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

DateFirmReason
2026-08-11Medline Industries, LPThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10American Contract Systems IncKits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. U
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-07-29Cardinal Health 200, LLCThe Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is
2026-07-20Medline Industries, LPDownstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the ap
2026-07-14Cardinal Health 200, LLCCardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability o
2026-07-10Medline Industries, LPKits contain a potentially contaminated component which were recalled by the manufacturer

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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.