AngioSculpt OTW PTA Scoring Balloon Catheter 2334-7040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813132022235), received between Aug 27, 2020 and Sep 18, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Entrapment of Device; Material Rupture

  An AngioSculpt catheter was used for a therapeutic peripheral procedure in the SFA. During inflation, the balloon immediately burst below RBP (RBP:14 atm) (device evaluated; no leak observed). A second AngioSculpt was used; however, the balloon popped instantly upon inflation (RBP:12 atm). The AngioSculpt and concomitant devices were removed all together. The procedure was completed with a non-AngioSculpt. No patient injury reported.This Product Problem is being submitted for the second AngioSculpt for balloon rupture and removal as a system; potential for harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50821269 ↗
• MalfunctionJul 26, 2022Material Rupture; Material Rupture

  TWO ANGIOSCULPT DEVICES (3005462046-2022-00038) WERE USED TO TREAT A MODERATELY CALCIFIED MID ILIAC. DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-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 15108561 ↗
• MalfunctionJul 26, 2022Material Rupture; Material Rupture

  TWO ANGIOSCULPT DEVICES (3005462046-2022-00037, 3005462046-2022-00038) WERE USED TO TREAT A MODERATELY CALCIFIED MID ILIAC. DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-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 15108438 ↗
• MalfunctionNov 17, 2020Material Rupture; Material Rupture

  DURING INFLATION BELOW RBP, THE BALLOON RUPTURED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10853989 ↗
• MalfunctionAug 27, 2020Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED DISTAL SFA. AFTER MULTIPLE INFLATIONS, THE BALLOON RUPTURED AT 14 ATM (RBP IS 12 ATM). THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10462688 ↗