Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter M5IVL6560Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M732M5IVL65600), received between Apr 3, 2020 and Mar 10, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 10, 2021Difficult to Remove; Difficult to Remove

  A SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) M5 6.5X60 DEVICE WAS USED FOR A SHORT (3MM), STRONGLY CALCIFIED CFA LESION (PROFUNDA). THE LESION WAS DIFFICULT TO CROSS WITH THE WIRE, BUT WAS ULTIMATELY ACHIEVED VIA RETROGRADE. THE VESSEL WAS PRE-DILATATED FIRST WITH 4.0MM BALLOON, FOLLOWED BY TREATMENT WITH THE IVL 6.5MM CATHETER WITH 4 CYCLES WITH A GOOD RESULT. THE PHYSICIAN EXPERIENCED RESISTANCE IN PULLING BACK THE IVL CATHETER TO THE TIP OF THE INTRODUCER SHEATH; THE PHYSICIAN ATTEMPTED TO PULL A LITTLE BIT HARDER WITHOUT SUCCESS SO THE SHEATH AND IVL CATHETER WERE REMOVED TOGETHER. FOLLOWING SUCCESSFUL REMOVAL OF THE IVL DEVICE, A NEW CROSSOVER SHEATH WAS ADVANCED, DURING WHICH A GUIDEWIRE SEPARATION WAS OBSERVED INSIDE THE PATIENT. NEW RETROGRADE ACCESS WAS OBTAINED, AND THE BROKEN WIRE WAS SUCCESSFULLY SNARED AND REMOVED FROM THE PATIENT. THE PHYSICIAN BELIEVES THAT THE GUIDEWIRE DAMAGE WAS INDIRECTLY CONNECTED WITH THE REMOVAL OF THE IVL CATHETER DUE TO THE FACT THAT THE FORCE REQUIRED TO PULL ON THE CATHETER WAS STRONGER THAN USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457880 ↗
• MalfunctionApr 3, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THERE IS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THE REPORT. THE SPECIFIC LESION TREATED IS UNKNOWN, BUT IT HAS BEEN CONFIRMED THAT THE PATIENT WAS TREATED WITH SHOCKWAVE M5 PERIPHERAL CATHETER. AT POST-PROCEDURE, IT WAS CONFIRMED THAT THE DISTAL PORTION OF THE CATHETER HAD TORN OFF. THE PROCEDURE INVOLVED A SHOCKWAVE DEVICE WAS USED ALONG WITH A 7F TERUMO SHEATH. CATHETER WAS COMPLETELY REMOVED WITH THE SHEATH. THE IVL RESULT WAS GOOD. ACCORDING TO THE REPORT, THERE WAS NO DEATH, SERIOUS INJURIES OR HARM ON THE PATIENT. IT WAS ALSO REPORTED THAT THERE WAS NO ADDITIONAL INTERVENTION REQUIRED. ADDITIONAL HOSPITALIZATION WAS NOT REQUIRED. THE SCENARIO OF THE GIVEN CASE POTENTIALLY COULD HAVE LED TO DEVICE EMBOLISM INTO THE PATIENT.

  Patient problems: No Information

  MAUDE report 9924705 ↗