Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter M5IVL4560Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00195451000140), received between May 7, 2025 and May 7, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Nonstandard Device; Delivered as Unsterile Product; Packaging Problem; Nonstandard Device; Delivered as Unsterile Product; Packaging Problem

  SHOCKWAVE MEDICAL RECEIVED A REPORT INVOLVING A SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER. IT WAS REPORTED THAT DURING A PROCEDURE IN THE OPERATING ROOM (OR), A CATHETER WAS REMOVED FROM ITS SEALED PACKAGING. UPON OPENING THE CARTON, IT WAS DISCOVERED THAT THE CATHETER POUCH HAD LABELS MARKED "NOT FOR HUMAN USE" AND "TEST SAMPLE," AND THE CATHETER HAD A "REJECTED" LABEL ATTACHED. IT WAS REPORTED THAT BLOOD WAS OBSERVED ON THE PACKAGING WHICH WAS LATER CONFIRMED TO BE FROM THE PHYSICIAN. ADDITIONALLY, IT WAS NOTED THAT THE CATHETER DID NOT COME INTO CONTACT WITH THE PATIENT, AND THE IVL TREATMENT WAS NOT USED TO COMPLETE THE PROCEDURE. THE METHOD USED TO COMPLETE THE PROCEDURE REMAINS UNKNOWN. SHOCKWAVE MEDICAL WILL CONTINUE TO FOLLOW UP ON THE EXPECTED RETURN OF THE DEVICE TO AID IN THE INVESTIGATION EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978001 ↗