Skip to content

Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter S4IVL2540 (UDI M732S4IVL25400)Recalls & 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
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M732S4IVL25400), received between Mar 18, 2020 and Mar 18, 2020 — classified as 1 death.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Death1

Recent adverse event reports

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

  • DeathMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PHYSICIAN WANTED TO USE SHOCKWAVE OFF LABEL AS HE FELT IT WAS THE BEST OPTION. HE WAS GOING TO BE TREATING A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD) THAT HAD DISEASE FROM MID TO DISTAL LAD. THE CIRCUMFLEX ARTERY WAS BYPASSED DUE TO DISEASE AND A NARROW LEFT MAIN. THE DOCTOR FIRST STENTED THE LEFT MAIN ARTERY (LM) TO ALLOW HIS GUIDE TO ENGAGE BETTER BUT ALSO TO ALLOW HIM TO USE A GUIDELINER. FOLLOWING THAT HE PRE-DILATED WITH A 2.5X30 BALLOON. THE CALCIFICATION WAS 30-40MM IN LENGTH. FOLLOWING THAT A 2.5X40 IVL CATHETER WAS INSERTED BUT DUE TO THE DISEASE THE CATHETER WAS ONLY ABLE TO PASS ABOUT A QUARTER OF THE WAY DOWN. THE DOCTOR DECIDED TO INFLATE, AT 2ATM AND 5 PULSES WERE DELIVERED, SUBSEQUENTLY THE PATIENT STARTED TO BRADY DOWN (HEART BEAT DROPPING). IVL DEVICE WAS REMOVED, ANGIOGRAM WAS PERFORMED WITH CONTRAST, AND NO PERFORATION NOTED. THE PHYSICIAN DECIDED HE WOULD ABORT IVL AND GO WITH STANDARD BALLOON/STENT APPROACH TO FIX THE LAD. THE PHYSICIAN DECIDED TO TREAT FURTHER WITH BALLOONS (STANDARD & NC). THE PHYSICIAN TRIED TO USE A GUIDELINER FURTHER DOWN IN THE VESSEL (LM AND LAD) AND SUBSEQUENTLY DEPLOYED A STENT (PLANNED). ALL DEVICES WERE REMOVED (NO

    Patient problems: Death

    MAUDE report 9851053 ↗

Other Percutaneous Catheter, Ultrasound devices

All Percutaneous Catheter, Ultrasound devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page