Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter S4IVLK3040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00195451000324), received between Apr 10, 2023 and Aug 26, 2025 — classified as 2 injuries.

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.

• InjuryAug 26, 2025Difficult to Remove; Detachment of Device or Device Component; Material Split, Cut or Torn; Difficult to Remove; Detachment of Device or Device Component; Material Split, Cut or Torn

  A SHOCKWAVE S4 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED AS PART OF AN ENDOVASCULAR TREATMENT OF THE RIGHT LOWER LIMB (TIBIAL RECANALIZATION VIA ANTEGRADE +/- RETROGRADE PUNCTURE OF THE PEDAL ARTERY). AFTER DELIVERING 2 SHOCKWAVE IVL PULSES, A PERFORATION OF THE BALLOON WAS OBSERVED. THE DEFLATED CATHETER REMAINED STUCK IN THE TIBIAL ARTERY. DESPITE STRONG TRACTION, THEY WERE UNABLE TO REMOVE THE CATHETER AND THE SHAFT BROKE. THE IVL BALLOON AND PART OF THE SHAFT REMAINED IN THE ARTERY. SINCE THE CHANCE TO REMOVE THE CATHETER TIP IMMEDIATELY WAS NOT AVAILABLE DUE TO THE PATIENT EXPERIENCING AN ARREST ON THE TABLE (UNAUTHORIZED TO THE BALLOON), IT WAS UNABLE TO BE RETRIEVED. IT WAS REPORTED THAT THE PATIENT SUFFERED A CARDIORESPIRATORY ARREST DUE TO ELEVATED BLOOD POTASSIUM LEVELS UNRELATED TO SHOCKWAVE. THEY MANAGED TO RESUSCITATE HIM AND DECIDED NOT TO CONTINUE THE PROCEDURE AND TO LEAVE THE BALLOON FRAGMENT IN THE TIBIAL ARTERY. THE PATIENT WAS TAKEN BACK 5 DAYS POST INDEX PROCEDURE TO ATTEMPT TO REMOVE THE FRAGMENT FROM THE ARTERY, BUT WITHOUT SUCCESS. AS A RESULT, THE PATIENT HAD TO REMAIN HOSPITALIZED. THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Cardiac Arrest; Foreign Body In Patient

  MAUDE report 22900374 ↗
• InjuryApr 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT LEG PERIPHERAL INTERVENTION USING SHOCKWAVE S4 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER. DUE TO POOR KIDNEY FUNCTION THE PATIENT PROCEDURE HAD TO BE DONE WITH C02 (CONTRAINDICATION/OFF LABEL) RATHER THAN CONTRAST. AFTER THE CATHETER SUCCESSFULLY DELIVERED 80 PULSES, THE BALLOON RUPTURED IN THE ARTERIES BELOW THE KNEE. AFTER RUPTURE, A THROMBUS WAS OBSERVED. IT WAS NOT NOTICED EARLIER BECAUSE OF THE CO2, AND IT IS UNKNOWN WHETHER THE THROMBUS WAS A RESULT OF THE PROCEDURE OR NOT. THE VESSEL COULD NOT BE VISUALIZED AS WELL. AN IN-DWELLING CATHETER WITH TISSUE PLASMINOGEN ACTIVATOR (TPA) DRIP WAS LEFT INSIDE THE PATIENT'S VESSEL TO DISSOLVE THE THROMBUS. THE PATIENT WAS REQUIRED TO HAVE AN ADDITIONAL HOSPITAL STAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 16707363 ↗