Lithoplasty® M732LPBC7060DX1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M732LPBC7060DX1), received between Nov 30, 2018 and Jan 8, 2020 — classified as 2 malfunctions.

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 16, 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.

• MalfunctionJan 8, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  BASED ON INFORMATION PROVIDED, THE PATIENT HAD DISTAL OCCLUSIVE DISEASE, CALCIFIED AORTA AND CALCIFIED BILATERAL ILIAC. ENDARTERECTOMY WAS PERFORMED ON ONE PERIPHERAL SECTION. THE RIGHT ILIAC WAS TREATED WITH SWMI 7.0 IVL DEVICE USING A 7FR, 23 CM SHEATH. 150 PULSES WERE DELIVERED AT 4 ATM, POST-IVL DILATION TO 6 ATM AND THEN TO 8ATM WHEN THE BALLOON BURST. WHEN THE IVL CATHETER WAS REMOVED, THE DISTAL PORTION OF THE BALLOON WAS MISSING. A SELF-EXPANDING STENT WAS PLACED AND THE PHYSICIAN BELIEVES THAT THE STENT HAD PINNED THE SEPARATED BALLOON PORTION AGAINST THE ILIAC WALLS. THE STENT PLACEMENT WAS PRE-PLANNED AND THE PHYSICIAN DID NOT CONSIDER THE STENT PLACEMENT AS ADDITIONAL INTERVENTION. THE PATIENT HAD NO DISTAL PULSE AT THE BEGINNING OF THE PROCEDURE, BUT HAD BOUNDING PULSE AT THE COMPLETION OF THE PROCEDURE. THE VESSEL APPEARED TO HAVE OPENED COMPLETELY POST-IVL. PHYSICIAN WAS PLEASED WITH THE OUTCOME AND WAS NOT OVERLY CONCERNED WITH THE DEVICE SEPARATION. THE PHYSICIAN FELT THAT THIS IS NOT A UNIQUE RISK TO SHOCKWAVE AND INDICATED THAT THIS COULD HAVE HAPPENED WITH ANY THERAPEUTIC DEVICE IN AN EXTREMELY STENOTIC ARTERY.

  Patient problems: Peripheral Vascular Disease

  MAUDE report 9565959 ↗
• MalfunctionNov 30, 2018Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn

  DURING A PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) PROCEDURE, AN IVL CATHETER EXPERIENCED A LOSS OF PRESSURE. THE CATHETER WAS INITIALLY DIFFICULT TO REMOVE ON ITS OWN, REQUIRING THAT BOTH THE IVL CATHETER AND GUIDEWIRE BE REMOVED TOGETHER. UPON EVALUATION OF THE CATHETER, IT WAS NOTICED THAT THE CATHETER WAS FUSED TO THE GUIDEWIRE AND A PORTION OF THE BALLOON ALONG WITH THE DISTAL BOND/TIP HAD SEPARATED FROM THE CATHETER. ALL OTHER CATHETER COMPONENTS APPEARED TO BE PRESENT. THE DISTAL PORTION OF THE CATHETER ALTHOUGH SEPARATED FROM THE MAIN SHAFT, WAS RETAINED ON THE GUIDEWIRE AND WAS ABLE TO BE REMOVED.

  Patient problems: Peripheral Vascular Disease

  MAUDE report 8120437 ↗