Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter L6IVL120030Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00195451000416), received between Oct 2, 2024 and Sep 8, 2026 — classified as 3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50679647 ↗
• DeathMay 22, 2026Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) YELLOW CARD INCIDENT REPORT (MHRA REFERENCE#: 2026/005/008/501/009) INVOLVING TWO SHOCKWAVE L6 PERIPHERAL IVL CATHETERS USED FOR TREATMENT OF A PATIENT'S HEAVILY CALCIFIED ILIAC ARTERIES. THE FIRST BALLOON WILL BE REPORTED UNDER (B)(6) AND THE SECOND UNDER (B)(6) (MDR 3015053858-2026-00044). IT WAS REPORTED THAT DURING A HYBRID PROCEDURE CONSISTING OF COMMON FEMORAL ENDARTERECTOMY WITH PATCHPLASTY AND ENDOVASCULAR ANGIOPLASTY WITH LITHOTRIPSY, KISSING IVL BALLOONS WERE PLACED IN THE ILIAC ARTERIES. THE FIRST SHOCKWAVE L6 12.0MM PERIPHERAL IVL CATHETER SUCCESSFULLY DELIVERED TEN IVL TREATMENT CYCLES (THREE HUNDRED (300) PULSES) TO THE LEFT ILIAC ARTERY WITHOUT INCIDENT. THE RIGHT ILIAC ARTERY WAS PRE-DILATATED WITH A BALLOON, FOLLOWED BY A SECOND SHOCKWAVE L6 10.0MM PERIPHERAL IVL CATHETER WHICH WAS INFLATED AT 2ATM AND DELIVERED ONE IVL TREATMENT CYCLE (THIRTY (30) PULSES) TO THE RIGHT ILIAC ARTERY. THE PATIENT THEN EXPERIENCED A SUDDEN DROP IN BLOOD PRESSURE DUE TO AN RUPTURE IN THE RIGHT ILIAC ARTERY DURING THE SECOND CYCLE. FOLLOWING THE RUPTURE OF THE RIGHT ILIAC ARTERY, THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 25261110 ↗
• DeathMay 22, 2026Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) YELLOW CARD INCIDENT REPORT (MHRA REFERENCE# 2026/005/008/501/009) INVOLVING TWO SHOCKWAVE L6 PERIPHERAL IVL CATHETERS USED FOR TREATMENT OF A PATIENT'S HEAVILY CALCIFIED ILIAC ARTERIES. THE FIRST BALLOON WILL BE REPORTED UNDER (B)(6) AND THE SECOND UNDER (B)(6), (3015053858-2026-00045). IT WAS REPORTED THAT DURING A HYBRID PROCEDURE CONSISTING OF COMMON FEMORAL ENDARTERECTOMY WITH PATCHPLASTY AND ENDOVASCULAR ANGIOPLASTY WITH LITHOTRIPSY, KISSING IVL BALLOONS WERE PLACED IN THE ILIAC ARTERIES. THE FIRST SHOCKWAVE L6 12.0MM PERIPHERAL IVL CATHETER SUCCESSFULLY DELIVERED TEN IVL TREATMENT CYCLES (THREE HUNDRED (300) PULSES) TO THE LEFT ILIAC ARTERY WITHOUT INCIDENT. THE RIGHT ILIAC ARTERY WAS PRE-DILATATED WITH A BALLOON, FOLLOWED BY A SECOND SHOCKWAVE L6 10.0MM PERIPHERAL IVL CATHETER WHICH WAS INFLATED AT 2ATM AND DELIVERED ONE IVL TREATMENT CYCLE (THIRTY (30) PULSES) TO THE RIGHT ILIAC ARTERY. THE PATIENT THEN EXPERIENCED A SUDDEN DROP IN BLOOD PRESSURE DUE TO AN RUPTURE IN THE RIGHT ILIAC ARTERY DURING THE SECOND CYCLE. FOLLOWING THE RUPTURE OF THE RIGHT ILIAC ARTERY, THE PATI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 25260973 ↗
• DeathApr 3, 2026Failure to Cycle

  A SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO AID IN PREPARATION FOR REMOVAL OF HIGHLY CALCIFIED 21-YEAR-OLD LEADS. THE IVL CATHETER WAS PREPPED USING A 65/35 CONTRAST MIXTURE. ALL CONNECTIONS BETWEEN THE CATHETER, CONNECTOR CABLE, AND GENERATOR WERE CONFIRMED SECURE. HOWEVER, THERE WAS AN ISSUE FULLY PURGING THE IVL DEVICE. AIR CONTINUED TO RETURN UNTIL THE INDEFLATOR AND STOPCOCK WERE CHANGED. AN ERROR 88 WAS ENCOUNTERED WITH THE USE OF THE IVL CATHETER, BUT IT IS UNKNOWN WHEN THE ERROR APPEARED. THUS, A SECOND IVL CATHETER WAS USED TO COMPLETE IVL TREATMENT. SEVERAL HOURS LATER, THE PATIENT EXPERIENCED DESTABILIZATION DURING AND AFTER LEAD REMOVAL ATTEMPTS. THE PATIENT PASSED AWAY 6 HOURS AFTER THE PROCEDURE WAS COMPLETED. THE PHYSICIAN DID NOT ATTRIBUTE ANY PATIENT SEQUALAE TO THE IVL DEVICES, AND BELIEVES THAT THE PATIENT'S DEATH RESULTED FROM A TEAR IN THE SUPERIOR VENA CAVA (SVC) AFTER THE ATTEMPTED LEAD IMPLANT, WITH THE SVC APPEARING TO HAVE BEEN DAMAGED DURING LEAD REMOVAL. THERE WAS NO FORMAL AUTOPSY PERFORMED, ALTHOUGH THE CHEST WAS OPENED AND THE TEAR WAS IDENTIFIED DURING THAT INSPECTION.

  Patient problems: Vascular Dissection

  MAUDE report 24776267 ↗
• InjuryFeb 26, 2026Inflation Problem; Leak/Splash; Stretched; Material Split, Cut or Torn

  IT WAS REPORTED THAT A SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE TO TREAT A LESION IN THE ILIAC ARTERY. A 75-YEAR-OLD MALE PATIENT WAS HOSPITALIZED FOR A THROMBOENDARTERECTOMY OF THE FEMORAL BIFURCATION WITH USE OF A SHOCKWAVE IVL BALLOON. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A SUDDEN DROP IN BLOOD PRESSURE DUE TO A RUPTURE IN THE ILIAC ARTERY. SHOCKWAVE IVL THERAPY WAS TEMPORARILY STOPPED TO MANAGE THE HEMORRHAGIC SHOCK. AFTER THE PATIENT MAINTAINED A SATISFACTORY MEAN ARTERIAL PRESSURE, SHOCKWAVE IVL THERAPY RESUMED. THE ORIGINAL IVL DEVICE WAS SUBSEQUENTLY REINSERTED FOLLOWING THE PATIENT'S HEART ATTACK DURING THE PROCEDURE. ACCESS WAS VIA AN IPSI-LATERAL RIGHT FEMORAL PUNCTURE USING AN 18FR INTRODUCER SHEATH AND A 0.018" GUIDEWIRE WITH A STANDARD ENDOVASCULAR ANEURYSM REPAIR (EVAR) SETUP; NO TAVR EQUIPMENT WAS USED. DURING REINFLATION OF THE IVL BALLOON, THE BALLOON DID NOT INFLATE AND A MAJOR LEAK OCCURRED AT THE JUNCTION BETWEEN THE DELIVERY CATHETER AND THE LATERAL INFLATION PORT. THREE IVL PULSE CYCLES WERE DELIVERED. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE IVL BALLOON, SIGNIFICANT ELONGATION OF THE DELIVERY CAT

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels; Shock

  MAUDE report 24460778 ↗
• MalfunctionNov 4, 2024Detachment 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 ARTERIES. THE IVL CATHETER DELIVERED 300 PULSES. IT WAS REPORTED THAT THE BALLOON PORTION OF THE CATHETER DETACHED FROM THE SHAFT UPON REMOVAL. THE BALLOON REMAINED ON THE 0.018" GUIDEWIRE, ALLOWING REMOVAL OF BOTH THE CATHETER AND BALLOON TOGETHER. A STENT WAS PLACED AS PLANNED, AND NO ADDITIONAL INTERVENTIONS WERE NECESSARY. THE FACILITY REPORTED THAT THE DETACHMENT OCCURRED WHILE THE GUIDEWIRE WAS STILL INSIDE THE PATIENT; HOWEVER, THERE WAS NO ADVERSE EVENT TO THE PATIENT, AND NO FRAGMENTS REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604323 ↗
• InjuryOct 2, 2024Adverse 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. THE VESSEL WAS PRE-DILATED WITH A 3.5MM X 100 MM STERLING BALLOON FOLLOWED BY A 4.0 STERLING BALLOON. DURING IVL TREATMENT, THE 12MM IVL CATHETER WAS PLACED IN THE PORTION OF THE VESSEL THAT MEASURED 7-8MM, CAUSING THE ARTERY TO RUPTURE. ABDOMINAL HEMORRHAGE AND LOSS OF BLOOD WAS ALSO NOTED. THE PATIENT REQUIRED CPR (CARDIOPULMONARY RESUSCITATION) AND A BLOOD TRANSFUSION. THE PHYSICIAN USED COVERED STENTS TO REPAIR THE RUPTURE. THE PATIENT WAS DOING FINE FOLLOWING THE PROCEDURE. WHILE THERE WAS NO REPORT OF IVL CATHETER MALFUNCTION, IT WAS REPORTED THAT THE PHYSICIAN WAS AWARE THAT THE 12MM IVL CATHETER WAS 40-50% OVERSIZED FOR THE PATIENT'S VESSEL SEGMENT AND THAT THE USE WAS OFF-LABEL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 20355904 ↗