Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter E8IVL060080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00195451000584), received between Feb 4, 2026 and Mar 30, 2026 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMar 30, 2026Detachment of Device or Device Component; Difficult to Advance

  A SHOCKWAVE E8 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE COMMON FEMORAL ARTERY VIA CONTRALATERAL FEMORAL ACCESS. THERE WAS NO RESISTANCE WHILE ADVANCING THE CATHETER OVER THE GUIDEWIRE OR THROUGH THE SHEATH. HOWEVER, IT WAS REPORTED THAT SEVERE ILIAC TORTUOSITY AND THE PRESENCE OF PRIOR ILIAC STENTS LIMITED THE ABILITY TO ADVANCE THE CATHETER. THE DEVICE WAS ADVANCED ACROSS THE AORTIC BIFURCATION BUT COULD NOT REACH THE TARGET LESION IN THE COMMON FEMORAL ARTERY. DURING CATHETER REMOVAL, THE E8 SHAFT FRACTURED AND THE BALLOON DETACHED. ALL COMPONENTS WERE SUCCESSFULLY RETRIEVED, AND NO FRAGMENTS WERE RETAINED IN THE PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722174 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED FROM THE SHOCKWAVE DISRUPT PAD JAPAN STUDY. A SHOCKWAVE E8 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE FEMOROPOPLITEAL ARTERY. THE FIRST IVL CATHETER USED BROKE WHILE ATTEMPTING TO INSERT THE DEVICE. THE DEVICE DID NOT ENTER THE PATIENT AND NO PULSES WERE DELIVERED. A SECOND SHOCKWAVE E8 PERIPHERAL IVL CATHETER WAS USED AND 400 IVL PULSES WERE SUCCESSFULLY DELIVERED TO THE TARGET LESION. FOUR DAYS POST-PROCEDURE, A SUPERFICIAL FEMORAL ARTERY (SFA) ACUTE OCCLUSION WAS OBSERVED, AND THE PATIENT WAS READMITTED TO THE HOSPITAL. THE PATIENT REPORTED SUDDEN NUMBNESS AND COLDNESS IN THE LEFT LOWER LEG. TWO DAYS LATER, THE PATIENT UNDERWENT THROMBECTOMY, AND TARGET LESION REVASCULARIZATION OF THE LEFT SFA, FOLLOWED BY A STENT PLACEMENT. THE PRINCIPAL INVESTIGATOR CONFIRMED THAT BLOOD FLOW TO THE LOWER LIMB IMPROVED SIGNIFICANTLY. THE PATIENT WAS DISCHARGED THREE DAYS AFTER. (THIS EVENT WAS PREVIOUSLY REPORTED VIA MDR# 3015053858-2025-00110.) ON (B)(6) 2026, FIVE (5) MONTHS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A REPORT OF SUDDEN NUMBNESS AND A COLD SENSATION IN THE LOWER LEFT LEG. AN ANGIOGRAM

  Patient problems: Obstruction/Occlusion

  MAUDE report 24264441 ↗