Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter M5PIVL5560Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00195451000249), received between Sep 27, 2022 and Aug 13, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Rupture” (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

Recent adverse event reports

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

• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. THE CATHETER WAS SUCCESSFULLY TRACKED INTO THE LESION WITH ALL 300 PULSES DELIVERED WITHOUT DIFFICULTY. UPON REMOVAL, THE PHYSICIAN NOTED A PIECE OF ARTERIAL INTIMA ATTACHED TO THE CATHETER, ALTHOUGH THERE WAS NO EVIDENCE OF VESSEL RUPTURE, AND THE REST OF THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: Vascular Dissection

  MAUDE report 22792826 ↗
• InjurySep 27, 2022Material Rupture

  SHOCKWAVE DEVICE RUPTURED IN PATIENT'S RIGHT LEG. REMOVED FROM BODY WITH NO HARM TO PATIENT. PHYSICIAN AWARE, DEVICE SAVED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498812 ↗