Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter S4IVLK4040Recalls & reported problems
Shockwave Medical, Inc. · 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). · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00195451000348), received between Jun 10, 2026 and Jun 10, 2026 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
A SHOCKWAVE S4 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE POPLITEAL ARTERY. A TOTAL OF 20 IVL PULSES WERE DELIVERED, DURING WHICH THE PATIENT EXPERIENCED LEG PAIN. THE PHYSICIAN PROCEEDED TO DELIVER A SUBSEQUENT CYCLE OF IVL PULSES, BUT THE PATIENT DECLINED CONTINUATION OF IVL TREATMENT DUE TO PAIN. THE PROCEDURE WAS COMPLETED USING ATHERECTOMY FOLLOWED BY DRUG-COATED BALLOON (DCB) ANGIOPLASTY, WITH NO REPORTED PATIENT HARM. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. DURING TREATMENT, THE PATIENT REPORTED DEEP, ACHING PAIN WITH A SEVERITY OF 7-8 ON A 10-POINT SCALE. ADDITIONALLY, THE PATIENT REPORTED MILD CALF PAIN AND BILATERAL LEG SWELLING.
Patient problems: Pain; Swelling/ Edema
MAUDE report 25459730 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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