Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter M5IVL6060 (UDI M732M5IVL60600)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M732M5IVL60600), received between May 29, 2021 and Dec 17, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2021Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn

  A SHOCKWAVE M5 PERIPHERAL LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA). THE IVL CATHETER COMPLETED ALL 300 PULSES WITHOUT INCIDENT. THE PHYSICIAN DECIDED TO GO BACK TO POST-DILATE THE PROXIMAL POPLITEAL TO PROXIMAL SFA WITH THE SAME IVL BALLOON AT 8ATM, WHICH IS OUTSIDE THE INSTRUCTIONS FOR USE FOR THE M5 DEVICE. DURING THE FINAL INFLATION, A BALLOON LOSS OF PRESSURE OCCURRED. UPON ATTEMPTED REMOVAL OF THE IVL CATHETER, THE BALLOON PORTION WAS FOUND TO BE DETACHED FROM THE IVL CATHETER. ANGIOGRAM WAS USED TO LOCATE THE DETACHED BALLOON IN THE PROXIMAL SFA. THE PHYSICIAN ELECTED TO PERFORM A SURGICAL CUTDOWN OF THE SFA TO RETRIEVE THE DETACHED BALLOON, AND ALL DETACHED COMPONENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE PHYSICIAN BELIEVES THAT A SHARP PIECE OF CALCIUM IN THE PROXIMAL SFA MAY HAVE CAUSED THE BALLOON LOSS OF PRESSURE AND SUBSEQUENT DETACHED COMPONENT. TO DATE, NO PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13029364 ↗
• MalfunctionMay 29, 2021Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn

  A M5 6.0X60 SHOCKWAVE IVL CATHETER WAS USED TO TREAT THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 150 PULSES AT 4 ATM IN THE PRESENCE OF NODULAR CALCIUM. AFTER THAT, THE PRESSURE WAS INCREASED TO 10 ATMS, WHICH IS BEYOND THE RECOMMENDED TREATMENT PRESSURE OF 4 ATM OF THE LABEL (OFF-LABEL), AND PULSED AT WHICH TIME THE BALLOON RUPTURED. THE PHYSICIAN WAS WELL AWARE THAT INCREASING THE PRESSURE CAN LEAD TO UN-PREDICTABILITY WITHIN THE BALLOON, BUT ELECTED TO PROCEED ANYWAY. UPON REMOVAL OF THE DEVICE, THE BALLOON PORTION GOT STUCK AT THE END OF THE DESTINATION SHEATH. THE PHYSICIAN ATTEMPTED MULTIPLE METHODS TO REMOVE THE CATHETER, AND DURING ONE OF THOSE ATTEMPTS, THE BALLOON SHEARED OFF THE CATHETER. A SNARE WAS USED IN AN ATTEMPT TO SNARE AND REMOVE THE BALLOON PORTION, BUT ONLY A PORTION OF THE DETACHED BALLOON COULD BE SNARED. A COVERED STENT WAS IMPLANTED TO STENT THE DETACHED BALLOON AGAINST THE VESSEL WALL AND OUT OF THE LUMEN. THE PHYSICIAN BELIEVE THAT THE COMBINATION OF NODULAR CALCIUM AND PULSING AT 10ATM'S LEAD TO A COMPLETE TEAR IN THE MATERIAL OF THE BALLOON THAT WOULD NOT ALLOW IT TO RE-WRAP PROPERLY TO BE REMOVED FROM BODY. THERE HAVE BEEN NO PATIENT SEQUELAE REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905519 ↗