AngioSculpt OTW PTA Scoring Balloon Catheter 2334-8040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813132022242), received between May 22, 2018 and Feb 24, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Material Rupture

  AN ANGIOSCULPT DEVICE WAS USED FOR A PERIPHERAL THERAPEUTIC PROCEDURE IN A MODERATELY CALCIFIED MID SFA. DURING INFLATION, THE BALLOON RUPTURED AT 6 ATM (RBP: 12 ATM). THE PROCEDURE WAS COMPLETED WITH A REGULAR BALLOON. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433297 ↗
• MalfunctionJul 16, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED LESION. DURING INFLATION AT 6 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH THE ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19753139 ↗
• MalfunctionMay 22, 2018Break; Burst Container or Vessel; Break; Burst Container or Vessel

  Patient problems: Atherosclerosis; Peripheral Vascular Disease

  MAUDE report 7532923 ↗