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Lithoplasty® M732LPBC4060DX1Recalls & reported problems

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

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 M732LPBC4060DX1), received between Mar 26, 2019 and Mar 26, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

  • Improper or Incorrect Procedure or Method1
  • Material Split, Cut or Torn1

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.

  • MalfunctionMar 26, 2019Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn

    A 4.0MM X 60MM AND 7.0MM X 60MM SHOCKWAVE IVL CATHETERS WERE INTRODUCED SIDE BY SIDE IN A HEAVILY CALCIFIED AND DISEASED AORTA. THE PHYSICIAN WAS USING A TECHNIQUE CALLED "KISSING BALLOONS". THEIR TREATMENT PLAN WAS TO PULSE EACH BALLOON SEPARATELY IN AN EFFORT TO MODIFY AN ECCENTRIC CALCIFIED LESION. AFTER SUCCESSFULLY DELIVERING IVL THERAPY TO THE LESION AND ACHIEVING POSITIVE RESULTS THE PHYSICIAN DECIDED TO PULL BACK THE 4MM BALLOON WITHOUT DEFLATING THE BALLOONS PRIOR TO PULLBACK, SO THE BALLOONS WERE PINNED TO EACH OTHER AND TO THE INTERIOR OF THE AORTA. THE BALLOONS EXPERIENCED TENSILE FORCE SUFFICIENT TO CAUSE THE BALLOON MATERIAL TO TEAR. IN ADDITION, THE CATHETER INNER MEMBER WAS DAMAGED AND BROKE INTO 2 PIECES. IMMEDIATELY UPON DETECTING THIS USE ERROR THE PHYSICIAN PROCEEDED TO REMEDY THE SITUATION BY SNARING AND REMOVING THE CATHETER PIECES. THE PHYSICIAN WAS CONFIDENT THAT ALL CATHETER COMPONENTS INCLUDING THE DISTAL END OF THE BALLOON WERE RETRIEVED. FOLLOW UP ANGIOGRAMS SHOWED EXCELLENT FLOW AND SUCCESSFUL TREATMENT. THERE WAS NO PATIENT HARM OR ADVERSE OUTCOME. PATIENT WAS DISCHARGED AND IS DOING WELL.

    Patient problems: Peripheral Vascular Disease

    MAUDE report 8454436 ↗

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Sources and updates

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