Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter L6IVL100030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00195451000409), received between Jun 6, 2023 and Aug 13, 2026 — classified as 2 deaths, 3 injuries, 1 malfunction.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50244968 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE ILIAC ARTERIES. 300 IVL PULSES WERE DELIVERED. WHEN THE BALLOON WAS DEFLATED, IT WAS DISCOVERED THAT THE ILIAC ARTERY HAD A PERFORATION. STENTING AND AN ILIAC ARTERY GRAFT SURGERY HAD TO BE PERFORMED TO TREAT THE PERFORATION. NO ADDITIONAL PATIENT HARM WAS REPORTED.

  Patient problems: Perforation of Vessels

  MAUDE report 22190914 ↗
• InjuryApr 25, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  A SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A CALCIFIED LESION IN THE ILIAC ARTERIES. THE PHYSICIAN SELECTED A 7FR SHEATH FOR THE IVL CATHETER WHICH IS SMALLER THAN THE RECOMMENDED SHEATH SIZE OF 8FR FOR A 10.0MM CATHETER PER THE DEVICE INSTRUCTIONS FOR USE. DURING THE PROCEDURE, 300 PULSES WERE SUCCESSFULLY DELIVERED. UPON REMOVAL OF THE IVL CATHETER, THE CATHETER BECAME STUCK IN THE 7FR SHEATH AND WAS NOT ABLE TO BE REMOVED. THE PHYSICIAN THEN USED A 20CC SYRINGE TO PULL NEGATIVE AND ATTEMPTED TO PULL OUT THE IVL CATHETER BUT ULTIMATELY HAD TO PULL THE ENTIRE SHEATH OUT. THE BALLOON DID NOT SEPARATE FROM THE CATHETER[?]THERE WAS NO KINKING OR FRAGMENTATION OF THE DEVICE, AND THE BALLOON REMAINED INTACT. WHEN THE PHYSICIAN PUT THE SHEATH BACK IN, THEY NOTICED THEY HAD DAMAGED THE TIP OF THE SHEATH. THEREFORE, A NEW SHEATH WAS OPENED BUT COULD NOT BE SUCCESSFULLY NAVIGATED BACK THROUGH THE ACCESS SITE. AN ANGIOGRAM REVEALED A PERFORATION OF THE EXTERNAL ILIAC ARTERY. SUBSEQUENTLY, BRACHIAL ACCESS WAS OBTAINED, AND A VIABAHN STENT WAS DEPLOYED TO SEAL THE PERFORATION, FOLLOWED BY POST-DILATION BALLOONING. A POST-DILATION BALLOON WAS USED AFTE

  Patient problems: Perforation of Vessels

  MAUDE report 21914537 ↗
• InjuryMar 20, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  A SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE RIGHT AND LEFT COMMON ILIAC ARTERIES. 280 PULSES WERE SUCCESSFULLY DELIVERED BEFORE A BALLOON LOSS OF PRESSURE OCCURRED. UPON REMOVAL, THE BALLOON BECAME DETACHED FROM THE IVL CATHETER. THE PROXIMAL END CAME OUT OVER THE SHEATH WHILE THE DISTAL TIP OF THE BALLOON REMAINED IN THE BODY AND WAS STUCK ON THE SHEATH. SNARING WAS PERFORMED TO REMOVE THE DETACHED PORTION OF THE IVL CATHETER. A DISSECTION/INJURY TO THE LEFT CFA WAS OBSERVED AFTER MULTIPLE SHEATH EXCHANGES AND SNARING OF THE DISTAL PORTION OF THE IVL CATHETER. THE PATIENT WAS SENT FROM THE CATHETER LAB TO THE OPERATING ROOM (OR) FOR A SURGICAL COMMON FETAL ARTERY (CFA) REPAIR. THE PATIENT HAD A SUCCESSFUL REPAIR OF THEIR CFA AND HAS SINCE BEEN DISCHARGED.

  Patient problems: Vascular Dissection

  MAUDE report 18947209 ↗
• DeathJul 10, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MITRAL VALVULOPLASTY PROCEDURE TO TREAT MITRAL STENOSIS USING THREE SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY CATHETERS. THE PROCEDURE WAS PERFORMED OFF-LABEL AND THE PHYSICIAN WAS AWARE OF IT. THE IVLS WERE INTRODUCED INTO THE PATIENT VIA TRANSSEPTAL PUNCTURE. DURING THE PROCEDURE AND AFTER 60 PULSES WERE DELIVERED, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN IMMEDIATELY REALIZED THAT THE 0.018" STEEL CORE WIRE PERFORATED THE LEFT VENTRICLE (LV). THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM (OR) FOR OPEN-HEART SURGERY TO FIX THE PERFORATION AND THEN MOVED TO THE INTENSIVE CARE UNIT (ICU). WHILE IN THE ICU, THE PATIENT STARTED TO BLEED AGAIN AND THEN SUBSEQUENTLY EXPIRED. ALL THREE IVL DEVICES FUNCTIONED AS INTENDED AND NO MALFUNCTION WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 17290260 ↗
• DeathJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WHERE TWO SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED AS PART OF AN OVERALL ENDOVASCULAR TREATMENT PLAN. THE CATHETERS WERE USED DURING THE CASE TO TREAT SEVERELY CALCIFIED LESIONS IN THE RIGHT AND LEFT COMMON ILIAC ARTERIES. THE IVL BALLOONS FUNCTIONED PROPERLY DURING THE CASE, DELIVERING 60 PULSES EACH AT APPROXIMATELY 4 ATMOSPHERES. THE BALLOONS WERE USED TO PRE-TREAT EACH ARTERY BEFORE DEPLOYING STENT GRAFT IN EACH ARTERY. REPORTEDLY, POST PROCEDURE, THE PATIENT EXPERIENCED RETROPERITONEAL BLEED. THE PATIENT WAS BROUGHT BACK IN THE CATH LAB HOWEVER, THE PATIENT EXPIRED.

  Patient problems: Hematoma; Retroperitoneal Hemorrhage

  MAUDE report 17074891 ↗