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Lithoplasty® M732LPBC5560DX1Recalls & reported problems

Shockwave Medical, Inc. · The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilation of otherwise difficult to treat calcified stenosis of the peripheral vasculature. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M732LPBC5560DX1), received between Dec 5, 2018 and Dec 5, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Split, Cut or Torn1
  • Patient Device Interaction Problem1

Patient problems

  • Peripheral Vascular Disease1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 5, 2018Patient Device Interaction Problem; Material Split, Cut or Torn; Patient Device Interaction Problem; Material Split, Cut or Torn

    A 6X60MM CATHETER WAS USED TO TREAT THE MID-SFA. AFTER THREE CYCLES OF TREATMENT, THERE WAS AN ATTEMPT TO INFLATE THE BALLOON BUT NO PRESSURE HELD. THE CATHETER WAS REMOVED. UPON EVALUATION OF THE CATHETER, IT WAS NOTICED THAT A PORTION OF THE BALLOON HAD SEPARATED FROM THE CATHETER. UNDER FLUORO, IT WAS IDENTIFIED AS BEING RETAINED ON THE GUIDEWIRE. THE BALLOON WAS THEN CAPTURED USING A SNARE AND REMOVED FROM THE BODY IN A SINGLE PIECE.

    Patient problems: Peripheral Vascular Disease

    MAUDE report 8134174 ↗

Other Percutaneous Catheter, Ultrasound devices

All Percutaneous Catheter, Ultrasound devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.