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Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter S4IVL3540Recalls & 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 M732S4IVL35400), received between Jun 13, 2019 and Jun 13, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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.

Most reported problems

Device problems

  • Material Split, Cut or Torn1

Patient problems

  • Ischemic Heart Disease1
  • Vascular Dissection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 13, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

    A SHOCKWAVE REPRESENTATIVE WAS MADE AWARE OF AN OFF-LABEL CASE BY THE PHYSICIAN WHERE A PERIPHERAL CATHETER WAS USED IN A CORONARY CASE. THE PHYSICIAN UNDERSTOOD THE PROCEDURE WAS OFF LABEL AND DETERMINED IT WAS THE ONLY TREATMENT OPTION FOR THE PATIENT. THE PHYSICIAN WAS TREATING THE LAD AND INDICATED A BALLOON RUPTURE DURING IVL TREATMENT AFTER APPROXIMATELY TWENTY PULSES. ACCORDING TO THE PHYSICIAN, DURING DELIVERY OF THERAPY TO THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, THE VESSEL DISSECTED INTO THE LAD, LEFT MAIN AND INTO THE AORTA. THE PHYSICIAN NOTED THE PATIENT WAS ALERT AND STABLE THE ENTIRE TIME AND THAT A DISSECTION WOULD HAVE OCCURRED WITH ANY DEVICE SINCE THE LAD WAS SO SEVERELY CALCIFIED. THE PHYSICIAN TREATED THE DISSECTION WITH STENTS IN THE LAD AND LEFT MAIN. THE PATIENT EXPERIENCED POST PROCEDURE CHEST PAIN, AN EKG WAS NORMAL, AND THE CT REVEALED AN INTRAMURAL HEMATOMA IN THE AORTA THAT WAS TREATED CONSERVATIVELY WITH MEDICAL MANAGEMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER 7 DAYS AND THE PLAN WAS TO SEE THE PATIENT IN THE OFFICE IN A FEW WEEKS. THE PHYSICIAN EXPECTS A FULL RECOVERY OF THE PATIENT.

    Patient problems: Ischemic Heart Disease; Vascular Dissection

    MAUDE report 8697738 ↗

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Sources and updates

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