AngioSculpt OTW PTA Scoring Balloon Catheter 2076-6040Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00813132021399), received between Aug 26, 2020 and Sep 16, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791917 ↗
• MalfunctionJul 1, 2026Material Rupture

  AN ANGIOSCULPT DEVICE WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING THE SECOND INFLATION AT 8 ATM (RBP: 14 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 25681007 ↗
• MalfunctionJan 26, 2026Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE. DURING THE FIRST INFLATION AT 10 ATM (RBP: 14 ATM), THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW 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 24179877 ↗
• MalfunctionNov 6, 2025Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT CATHETER WAS USED IN A PERIPHERAL PROCEDURE IN THE MID SFA. DURING USE, THE ANGIOSCULPT BECAME STUCK ON THE NON-PHILIPS GUIDEWIRE AND HAD TO BE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO REMOVAL AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491049 ↗
• MalfunctionSep 10, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING THE FIRST 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 23017745 ↗
• MalfunctionJun 27, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE OF THE MID SFA. DURING THE SECOND INFLATION AT 10 ATM (RBP 14 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 22344860 ↗
• MalfunctionMay 22, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE IN THE MID SFA. DURING THE FIRST INFLATION AT 6 ATM (RBP 14 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 22073003 ↗
• MalfunctionNov 2, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID SFA. DURING INFLATION BELOW RBP, 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 12738784 ↗
• MalfunctionSep 30, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A PERIPHERAL LESION. DURING THE FIRST INFLATION AT 4-6 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 12555768 ↗
• MalfunctionJul 28, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID SFA. DURING THE FIRST INFLATION AT 8 ATM FOR 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243392 ↗
• MalfunctionJun 9, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN THE MID SFA AND DURING THE SECOND INFLATION OF MORE THAN NOMINAL PRESSURE AND LESS THAN RBP, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971455 ↗
• MalfunctionMar 23, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED AND SEVERELY TORTUOUS PROXIMAL ILLIAC. DURING THE 6TH INFLATION AT 14 ATM FOR 5 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554875 ↗
• MalfunctionFeb 1, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE PROXIMAL SFA. DURING INFLATION BELOW NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11263250 ↗
• MalfunctionSep 17, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED AND SEVERELY TORTUOUS MID SFA. DURING INFLATION AT 12 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10547223 ↗
• MalfunctionSep 2, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS MID SFA. DURING INFLATION AT 12 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10486030 ↗
• 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. DURING THE SECOND OR THIRD INFLATION, THE BALLOON RUPTURED AT 16 ATM (RBP IS 14 ATM). THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10462766 ↗
• MalfunctionAug 26, 2020Material Rupture; Material Rupture

  PRIOR TO THE ANGIOSCULPT DEVICE, MULTIPLE COMPETITOR DEVICES (BOSTON MUSTANG) WERE USED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS MID SFA, RESULTING IN INADEQUATE EXPANSION OF THE LESION. THEN AN ANGIOSCULPT DEVICE WAS USED WITH SOME EXPANSION, HOWEVER DURING THE FIRST INFLATION AT 14 ATM FOR 15 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH MULTIPLE COMPETITOR DEVICES (BOSTON MUSTANG, MEDTRONIC IN.PACT DCB). NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10455149 ↗