Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter L6IVL090030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00195451000393), received between Jun 17, 2025 and Mar 9, 2026 — 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.

• MalfunctionMar 9, 2026Difficult to Remove; Stretched; Detachment of Device or Device Component; Difficult to Advance

  A SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE COMMON ILIAC ARTERY AND DISTAL AORTA. IT WAS REPORTED THAT WHILE ATTEMPTING TO ADVANCE THE BALLOON CATHETER OVER THE GUIDEWIRE, THERE WAS SOME RESISTANCE. DURING REMOVAL OF THE DEVICE FROM THE PATIENT, RESISTANCE WAS AGAIN ENCOUNTERED. THE BALLOON APPEARED TO BE FULLY DEFLATED PRIOR TO REMOVAL. HOWEVER, AS IT STRETCHED DURING EXTRACTION, IT LIKELY DREW FLUID BACK IN AND BECAME STUCK ON THE GUIDEWIRE. THE SHEATH WAS WITHDRAWN AND THE GUIDEWIRE WAS CUT TO FACILITATE RETRIEVAL OF THE DEVICE. THE BALLOON SEPARATED AND CAME APART FROM THE CATHETER AS IT WAS BEING REMOVED. THE CATHETER BUT WAS SUCCESSFULLY REMOVED USING SIMPLE TRACTION. THERE WERE NO CATHETER FRAGMENTS RETAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ISSUES, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552666 ↗
• MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE ILIAC ARTERY. 300 IVL PULSES WERE DELIVERED SUCCESSFULLY. A DETACHMENT OCCURRED DURING IVL CATHETER REMOVAL, RESULTING IN THE CATHETER BREAKING INTO TWO PIECES. THE IVL BALLOON WAS FULLY DEFLATED, AND NO EXCESSIVE FORCE WAS APPLIED DURING REMOVAL. THE DETACHED COMPONENTS WERE RETRIEVED IN THE INTRODUCER SHEATH AND WERE NOT LEFT INSIDE THE PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22245366 ↗