AngioSculpt OTW PTA Scoring Balloon Catheter 2076-5020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813132021368), received between Jan 21, 2020 and Jun 7, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID SFA. DURING THE FIRST INFLATION AT 10 ATM FOR 15 SECONDS, 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 17083369 ↗
• MalfunctionAug 9, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE DISTAL SFA. DURING THE SECOND INFLATION AT 8 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW 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 15196227 ↗
• MalfunctionAug 26, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A MODERATELY CALCIFIED SFA. DURING THE FIRST INFLATION UNDER NOMINAL PRESSURE, THE BALLOON COULD NOT BE INFLATED AND APPEARED TO BE LEAKING AIR. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10454607 ↗
• MalfunctionJan 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE PULMONARY ARTERY AND WAS INFLATED 3 TIMES AT LESS THAN 14 ATM (RBP). DURING WITHDRAWAL THROUGH THE SHEATH, RESISTANCE WAS MET. UPON REMOVAL, THE PROXIMAL PORTION OF THE SCORING ELEMENT WAS DETACHED, BUT NOT TOTALLY SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9614189 ↗