Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter S4IVLK2540Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00195451000317), received between Jul 3, 2024 and Jul 3, 2024 — 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.

Most reported problems

Recent adverse event reports

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

• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE S4 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE LEFT PERONEAL ARTERIES FOR THE BTK II CLINICAL STUDY. THE SUBJECT WAS ADMITTED WITH NECROTIC, ISCHEMIC, MUMMIFIED TOES TO THE LEFT FOOT. THE IVL CATHETER SUCCESSFULLY DELIVERED 160 PULSES TO TREAT THE LESION AND THERE WAS NO DEVICE MALFUNCTION REPORTED. THE PATIENT WAS THEN ADMITTED 4 DAYS POST INDEX PROCEDURE FOR A LEFT TRANS-METATARSAL AMPUTATION (TMA) WHICH WAS PERFORMED WITHOUT ANY ISSUE. THE PATIENT WAS THEN DISCHARGED A FEW DAYS LATER WITH NO EVIDENCE OF ANY ADVERSE EVENTS AT DISCHARGE. 11 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED FOR WOUND DEHISCENCE RELATING TO THE TMA. AN INTERVENTION WAS PERFORMED WHERE WOUND DEBRIDEMENT WAS PERFORMED, AND A WOUND VACUUM WAS USED TO TREAT THE WOUND DEHISCENCE. MEDICATIONS AND OCCUPATIONAL THERAPY WERE PRESCRIBED. THE SITE REPORTED THESE EVENTS AS UNRELATED TO THE IVL DEVICE AND PROCEDURE. 3 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DEVELOPED RIGHT LEG PERIPHERAL VASCULAR DISEASE (PVD) WITH A PLANNED RIGHT LOWER EXTREMITY INTERVENTION. 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH ISCHEMIA AND REQUIRED

  Patient problems: Ischemia

  MAUDE report 19671909 ↗