AngioSculpt OTW PTA Scoring Balloon Catheter 2092-6040Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00813132021436), received between Jun 30, 2020 and Jun 15, 2026 — classified as 1 injury, 40 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (40 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Material Rupture

  AN ANGIOSCULPT DEVICE WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING THE FIRST INFLATION AT NOMINAL PRESSURE (NOMINAL: 8 ATM, RBP: 14 ATM), THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW EQUIVALENT PRODUCT. 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 25511573 ↗
• MalfunctionMay 20, 2026Material Rupture

  AN ANGIOSCULPT DEVICE WAS USED FOR A PERIPHERAL THERAPEUTIC PROCEDURE. DURING FIRST INFLATION AT 2 ATM (RBP: 14 ATM), THE BALLOON FAILED TO EXPAND. WHEN WATER WAS FLUSHED THROUGH THE BALLOON, A PINHOLE WAS IDENTIFIED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT. 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 25236397 ↗
• MalfunctionApr 21, 2026Material Separation

  AN ANGIOSCULPT CATHETER WAS USED FOR A PERIPHERAL ARTERIOVENOUS (AV) SHUNT PROCEDURE. DURING ADVANCEMENT, THE BALLOON COULD NOT CROSS THROUGH THE ANASTOMOSIS SITE. WHEN ATTEMPTING TO WITHDRAW THE UNINFLATED BALLOON FROM THE SHEATH, IT BECAME STUCK INSIDE AND COULD NOT BE RETRIEVED. STRONG TRACTION WAS APPLIED TO THE SHAFT BUT THE SCORING ELEMENT SEPARATED; REMOVING THE SHEATH AND CATHETER TOGETHER. THE SEPARATED SCORING ELEMENT WAS ABLE TO BE REMOVED SINCE IT WAS PROTRUDING THROUGH THE SKIN, KEEPING THE GUIDEWIRE IN PLACE. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. ALTHOUGH THE COMPLAINT DETAILS STATE THE BALLOON WAS UNINFLATED, A PHOTO PROVIDED BY THE CUSTOMER SHOWS AN INFLATED BALLOON. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO SCORING ELEMENT SEPARATION; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945014 ↗
• MalfunctionMar 20, 2026Material Rupture

  AN ANGIOSCULPT DEVICE WAS USED FOR A PERIPHERAL THERAPEUTIC PROCEDURE IN THE SFA. DURING USE, THE BALLOON RUPTURED UNDER NOMINAL PRESSURE (NOMINAL: 8 ATM, RBP: 14 ATM). THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON CATHETER. 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 24656280 ↗
• MalfunctionSep 9, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING THE FIRST INFLATION AT 12 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 23004249 ↗
• MalfunctionAug 18, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING THE FIRST INFLATION AT 14 ATM (RBP), 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 AT RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835025 ↗
• MalfunctionJun 5, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE OF A SEVERELY CALCIFIED SFA. DURING THE FIRST INFLATION AT 6 ATM (RBP 14 ATM), 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 22155700 ↗
• MalfunctionMay 23, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE OF A MODERATELY CALCIFIED LESION. DURING THE THIRD INFLATION AT 14 ATM (RBP), 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 AT RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079706 ↗
• MalfunctionApr 24, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE. DURING THE SECOND INFLATION AT 14 ATM (RBP), 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 AT RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902573 ↗
• MalfunctionOct 22, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE SFA. DURING THE FIRST INFLATION AT NOMINAL PRESSURE (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 20511041 ↗
• MalfunctionJul 5, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID SFA. DURING THE FIRST INFLATION AT NOMINAL PRESSURE (8 ATM), 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 19684297 ↗
• MalfunctionMar 19, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY PLAQUED MID PERONEAL ARTERY. DURING THE THIRD INFLATION AT 12 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 18935730 ↗
• MalfunctionMar 19, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED RADIAL VEIN. DURING THE SECOND INFLATION AT 20 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE BALLOON RUPTURED ABOVE RBP (14 ATM). THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935580 ↗
• MalfunctionJun 7, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE DISTAL SFA. DURING THE FIRST INFLATION AT 6 ATM FOR 5 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 17082584 ↗
• MalfunctionApr 4, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN THE ILIAC ARTERY. DURING THE FIRST INFLATION BELOW 8 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT. 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 16674991 ↗
• MalfunctionJan 17, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID RADIAL ARTERY. DURING THE FIRST INFLATION AT 8 ATM, THE BALLOON INFLATED TO A BAD SHAPE. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. DURING THE RETURNED PRODUCT ANALYSIS, A PINHOLE BALLOON RUPTURE WAS OBSERVED ON THE DISTAL PORTION OF THE BALLOON. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16188922 ↗
• MalfunctionDec 15, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID ILIAC ARTERY. DURING THE SECOND INFLATION AT NOMINAL PRESSURE (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 15992709 ↗
• MalfunctionFeb 15, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SLIGHTLY CALCIFIED PERIPHERAL LESION. DURING INFLATION, THE BALLOON COULD NOT BE INFLATED OVER 10 ATM DUE TO A LEAK ON THE HUB. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. DURING THE RETURNED DEVICE EVALUATION, A BALLOON RUPTURE WAS OBSERVED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13539095 ↗
• MalfunctionJan 31, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A PERIPHERAL LESION. DURING THE THIRD INFLATION FROM 8 ATM TO 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 AT RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13402642 ↗
• MalfunctionJan 11, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SLIGHTLY CALCIFIED PERIPHERAL LESION. DURING THE FIRST INFLATION AT 16 ATM FOR 5 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE BALLOON RUPTURED ABOVE RBP. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13226860 ↗
• MalfunctionJan 10, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SLIGHTLY CALCIFIED PERIPHERAL LESION. DURING THE SECOND INFLATION AT 18 ATM FOR 5 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE BALLOON RUPTURED ABOVE RBP. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13210809 ↗
• MalfunctionDec 28, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID SFA. DURING THE THIRD INFLATION AT 10 ATM FOR 10 SECONDS, 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 13101760 ↗
• MalfunctionDec 2, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SLIGHTLY CALCIFIED MID SFA. DURING THE FIRST INFLATION AT 10 ATM FOR 10 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED PER FDA REQUEST BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12921094 ↗
• MalfunctionAug 12, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A PERIPHERAL LESION. DURING MULTIPLE INFLATIONS AT 2 ATM AND 10 ATM, THE BALLOON COULD NOT BE INFLATED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. DEVICE ANALYSIS PERFORMED ON (B)(6) 2021 CONFIRMED A BALLOON RUPTURE. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316259 ↗
• MalfunctionJul 6, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE PERIPHERAL LESION. DURING THE THIRD INFLATION AT 8 ATM FOR 10 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 12125365 ↗