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Lithoplasty® M732LPBC5060DX1Recalls & 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

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 M732LPBC5060DX1), received between Jul 27, 2020 and Jul 27, 2020 — 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 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.

  • MalfunctionJul 27, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

    THE SHOCKWAVE COMPLAINTS TEAM REACHED OUT TO THE OPERATING PHYSICIAN WHO PROVIDED THE FOLLOWING INFORMATION ABOUT THE CASE: THE PATIENT WAS APPROXIMATELY IN THEIR LATE 60S/EARLY 70S WITH A HISTORY OF HYPERTENSION AND LIKELY A SMOKER. THE PATIENT INDICATED A HIGH DEGREE OF CALCIFICATION (CORAL REEF KIND) AND HENCE SHOCKWAVE IVL THERAPY WAS CHOSEN. IVL THERAPY WAS PROVIDED TO THE FEMORAL ARTERY PER THE IFU AT 4ATM WHEN HE NOTICED THAT THE IVL DEVICE LOST PRESSURE. AT SOME POINT IN THE PROCEDURE THE GRAND SLAM GUIDEWIRE KINKED, MAKING IT DIFFICULT TO WITHDRAW AND THE PHYSICIAN HAD TO RETRIEVE BOTH THE WIRE AND IVL CATHETER TOGETHER. THE PHYSICIAN CONFIRMED THAT THE CORRECT SHEATH SIZE WAS USED, HOWEVER SOME RESISTANCE WAS FELT DURING WITHDRAWAL AND ADDITIONAL FORCE HAD TO BE EXERTED TO WITHDRAW THE DEVICE. THE INTENT WAS TO CONTINUE THE PROCEDURE FURTHER WITH A NON-IVL DEVICE WHEN THE MARKER BAND WAS NOTICED UNDER FLUOROSCOPY. THE WITHDRAWN IVL CATHETER WAS INSPECTED AND IT WAS NOTICED THAT ABOUT HALF OF THE DISTAL BALLOON PORTION WAS MISSING. A SNARE METHOD WAS USED TO REMOVE THE SEPARATED PIECES AND THE PHYSICIAN CONFIRMED THAT NOTHING WAS LEFT BEHIND IN THE PATIENT. THE FINAL PATIE

    Patient problems: Peripheral Vascular Disease

    MAUDE report 10330088 ↗

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.