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Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter S4IVL3040Recalls & 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

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00195451000058), received between Sep 19, 2022 and Dec 2, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Insufficient Device Problem Information1

Patient problems

  • Cardiogenic Shock1
  • Hemorrhage/Blood Loss/Bleeding1
  • Pain1
  • Post Operative Wound Infection1
  • Pseudoaneurysm1
  • Restenosis1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    POST BTK II STUDY USING A SHOCKWAVE PERIPHERAL LITHOTRIPSY CATHETER, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) DUE TO SEVERAL DAYS OF LEFT KNEE PAIN. THE STAFF TOOK X-RAYS AND WAS DISCHARGED TO HOME. THE PATIENT RETURNED TO THE ED AND UNDERWENT A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) TO THE CHEST, ABDOMEN, AND PELVIS. IT WAS FOUND THAT THERE WAS EXTRAVASATION OF THE LEFT EXTERNAL ILIAC ARTERY (EIA) PSEUDOANEURYSM. THE PATIENT WAS PROVIDED 2.25 LITERS OF INTRAVENOUS FLUIDS AND 3 UNITS OF PACKED RED BLOOD CELLS (PRBC) DUE TO BLOOD LOSS. THE PATIENT ALSO STARTED ON LEVOPHED (NOREPINEPHRINE BITARTRATE). AS OF THIS DATE (B)(6) 2022, THE PATIENT IS STILL IN THE HOSPITAL.

    Patient problems: Cardiogenic Shock; Hemorrhage/Blood Loss/Bleeding; Pain; Pseudoaneurysm

    MAUDE report 15911914 ↗
  • InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    THIS REPORT IS BEING SUBMITTED BY SHOCKWAVE MEDICAL, INC. REGARDING THE PERIPHERAL S4 INTRAVASCULAR LITHOTRIPSY CATHETER (S4IVL) WHICH WAS USED IN A CLINICAL BTK II STUDY. IT WAS REPORTED THAT A PATIENT PRESENTED AT THE HOSPITAL POST PROCEDURE ON (B)(6) 2022. IT WAS FOUND THAT THERE WAS A LESION REVASCULARIZATION IN THE LEFT ANTERIOR TIBIAL ARTERY OF THE TREATED LEFT LEG. REPORTEDLY, THE ADVERSE EVENT HAS A PROBABLE RELATIONSHIP TO THE DEVICE, BUT IT HAS NO RELATIONSHIP TO THE PROCEDURE. THE REPORTED ADVERSE EVENT WAS RESOLVED ON (B)(6) 2022 WITH PERCUTANEOUS THERAPY AND WITH A CUTTING BALLOON.

    Patient problems: Post Operative Wound Infection; Restenosis

    MAUDE report 15451349 ↗

Other Percutaneous Catheter, Ultrasound devices

All Percutaneous Catheter, Ultrasound devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.