Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter M5IVL5060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00195451000157), received between Dec 6, 2021 and Dec 26, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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.

• MalfunctionDec 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO SUCCESSFULLY TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). WHILE ATTEMPTING TO REMOVE THE CATHETER FROM THE SHEATH, A DETACHMENT OCCURRED, AND A FRAGMENT OF THE BALLOON FELL INSIDE THE PATIENT. THE SEPARATION OCCURRED WHILE THE BALLOON WAS FULLY DEFLATED. THE PHYSICIAN USED A SPECIALIZED DEVICE TO RETRIEVE AND TAKE OUT THE FRAGMENT. A SECOND IVL CATHETER WAS USED TO COMPLETE THE SURGERY. THERE WAS NO REPORTED PATIENT HARM. THE PHYSICIAN ATTRIBUTED THE SEPARATION TO QUALITY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023666 ↗
• MalfunctionDec 6, 2021Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn

  A SHOCKWAVE M5 PERIPHERAL LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE SHOCKWAVE M5 PERIPHERAL LITHOTRIPSY (IVL) DEVICE SHOWED A BALLOON LOSS OF PRESSURE AT THE SECOND CYCLE OF PULSES. THE PHYSICIAN THEN STARTED TO PULL THE CATHETER OUT AND, UPON REMOVAL, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE IVL CATHETER GOT TRAPPED INTO THE INTRODUCER SHEATH CAUSING PART OF THE IVL BALLOON TO BREAK OFF. A PORTION OF THE IVL BALLOON REMAINED IN THE ARTERY OF THE PATIENT, THE PHYSICIAN ELECTED NOT TO TREAT/REMOVE THE DETACHED COMPONENT DUE TO THE CRITICAL CONDITION OF THE PATIENT. AS OF THE DATE OF THIS REPORT, NO PATIENT SEQUELAE HAVE BEEN REPORTED.

  Patient problems: Foreign Body Embolism

  MAUDE report 12937176 ↗