Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter M5PIVL6560Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00195451000263), received between Jul 24, 2024 and Feb 21, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL (SFA)/POPLITEAL ARTERY. DURING THE PROCEDURE, THE CATHETER TIP AND BALLOON DETACHED WHILE THE PHYSICIAN WAS REMOVING THE DEVICE FROM THE PATIENT'S BODY. THERE WAS NO INDICATION OF EXCESSIVE FORCE DURING THE REMOVAL OR MANIPULATION OF THE DEVICE. THE BALLOON HAD RUPTURED WHILE PULSING PRIOR TO THE REMOVAL ATTEMPT AND WAS FULLY DEFLATED AT THE TIME OF DETACHMENT. THE DETACHED FRAGMENT REMAINED WITHIN THE SUBINTIMAL SPACE AND COULD NOT BE RETRIEVED. A VIABAHN STENT WAS USED TO COVER THE DETACHED COMPONENT. THE DEVICE DID NOT PASS THROUGH ANY EXISTING STENTS IN THE VESSEL BEFORE TREATMENT WITH THE SHOCKWAVE DEVICE. THE PHYSICIAN'S PERSPECTIVE ON THE CAUSE OF THE EVENT IS UNKNOWN. THE PATIENT, A MALE, HAD UNKNOWN DEMOGRAPHICS AND MEDICAL CONDITION BUT WAS REPORTED TO BE DOING WELL AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439181 ↗
• InjuryJul 24, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT LESIONS IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND COMMON FEMORAL ARTERY (CFA). THE PHYSICIAN WAS UNABLE TO PASS THE CATHETER TO TREAT THE INTENDED LESION. 300 PULSES WERE DELIVERED IN THE CFA TO HELP WITH ADVANCEMENT. A SECOND M5+ IVL CATHETER WAS ATTEMPTED TO BE USED BUT FAILED TO ADVANCE TO THE INTENDED LESION, KINKING THE GUIDEWIRE IN THE PROCESS. THE PHYSICIAN ENCOUNTERED DIFFICULTIES IN REMOVING THE IVL CATHETER AND CUT THE IVL CATHETER MULTIPLE TIMES TO REMOVE FROM THE PATIENT. A LENGTH IN PROCEDURE TIME WAS NOTED. IT WAS REPORTED THAT THE FILTER WIRE CAUSED A DISSECTION IN THE POPLITEAL AREA. IT IS NOT KNOWN HOW THE DISSECTION WAS TREATED. THE CURRENT PATIENT STATUS IS UNKNOWN AND MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. THIS REPORT IS FOR THE SECOND IVL CATHETER USED IN THE PROCEDURE. REFER TO MDR# 3015053858-2024-00076 FOR THE FIRST CATHETER.

  Patient problems: Vascular Dissection

  MAUDE report 19822979 ↗
• InjuryJul 24, 2024Difficult to Advance; Difficult to Advance

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT LESIONS IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND COMMON FEMORAL ARTERY (CFA). THE PHYSICIAN WAS UNABLE TO PASS THE CATHETER TO TREAT THE INTENDED LESION. 300 PULSES WERE DELIVERED IN THE CFA TO HELP WITH ADVANCEMENT. A SECOND M5+ IVL CATHETER WAS ATTEMPTED TO BE USED BUT FAILED TO ADVANCE TO THE INTENDED LESION, KINKING THE GUIDEWIRE IN THE PROCESS. THE PHYSICIAN ENCOUNTERED DIFFICULTIES IN REMOVING THE IVL CATHETER AND CUT THE IVL CATHETER MULTIPLE TIMES TO REMOVE FROM THE PATIENT. A LENGTH IN PROCEDURE TIME WAS NOTED. IT WAS REPORTED THAT THE FILTER WIRE CAUSED A DISSECTION IN THE POPLITEAL AREA. IT IS NOT KNOWN HOW THE DISSECTION WAS TREATED. THE CURRENT PATIENT STATUS IS UNKNOWN AND MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. THIS REPORT IS FOR THE FIRST IVL CATHETER USED IN THE PROCEDURE. REFER TO MDR# 3015053858-2024-00077 FOR THE SECOND CATHETER.

  Patient problems: Vascular Dissection

  MAUDE report 19822977 ↗