Lithoplasty® M732LPBC3560DX1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M732LPBC3560DX1), received between Jul 2, 2019 and Jul 2, 2019 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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.

• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SHOCKWAVE MEDICAL WAS MADE AWARE OF AN INCIDENT POTENTIALLY INVOLVING ONE OF THE COMPANY'S MARKETED IVL DEVICES THROUGH A SOCIAL MEDIA POSTING ON (B)(6) 2019. THE TWITTER POSTING INDICATED THAT A VESSEL HAD RUPTURED DURING THE LITHOTRIPSY PROCEDURE WHILE TREATING THE ANTERIOR TIBIAL ARTERY. ACCORDING TO THE POST, THE PROCEDURE WAS DONE IN ACCORDANCE WITH THE IFU. NO ATHERECTOMY OR PREVIOUS BALLOON ANGIOPLASTY WAS PERFORMED. THE RUPTURE WAS TREATED WITH A VIABAHN COVERED STENT TO SEAL THE AFFECTED AREA. FINAL FLUOROSCOPY IMAGES SHOWED THAT THE RUPTURE WAS SUCCESSFULLY COVERED. FOLLOW UP INFORMATION FROM THE PHYSICIAN INDICATED THAT THE DISSECTION WAS MOST LIKELY DUE TO BALLOON EXPANSION, AND NOT AS A RESULT OF THE IVL THERAPY. PER LAST COMMUNICATION, THE PHYSICIAN INDICATED THAT THE PATIENT WAS DOING FINE. ADDITIONAL CASE DETAILS ARE LIMITED, AND DESPITE THE MULTIPLE ATTEMPTS BY THE COMPANY TO OBTAIN FURTHER CASE AND PATIENT INFORMATION, VERY LITTLE WAS PROVIDED. THEREFORE, SHOCKWAVE IS SUBMITTING THIS REPORTABLE EVENT OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Peripheral Vascular Disease

  MAUDE report 8755895 ↗