AngioSculpt OTW PTA Scoring Balloon Catheter 2105-6040Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00813132021450), received between Aug 13, 2020 and Sep 23, 2026 — classified as 1 injury, 16 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.

• InjurySep 23, 2026Material Rupture; Material Separation

  An AngioSculpt catheter was used for a peripheral therapeutic procedure in a moderately tortuous AV shunt. During use, at initial inflation, the balloon ruptured at 14 atm (RBP). When the catheter was being removed, resistance was encountered, and the balloon with the distal tip separated within the patient (photo provided). The remaining portion of the catheter, including the scoring element, was removed from the patient. The retained balloon was subsequently retrieved with a snare, and angiogram confirmed nothing was left in the patient. The procedure was completed with no patient injury reported.This Adverse Event and Product Problem is being submitted for balloon rupture and separation; requiring intervention.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870253 ↗
• MalfunctionMay 13, 2026Material Rupture

  AN ANGIOSCULPT DEVICE WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING THE FIRST INFLATION AT 4 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 25165313 ↗
• MalfunctionFeb 5, 2026Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED FOR A PERIPHERAL PROCEDURE IN THE DISTAL CEPHALIC VEIN. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE (8 ATM). THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. DURING THE RETURNED PRODUCT EVALUATION, VISUAL INSPECTION CONFIRMED A BALLOON RADIAL BURST. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE BALLOON RADIAL BURST THAT CAN RESULT IN A POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272036 ↗
• MalfunctionJan 14, 2026Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE FOR AN AV-SHUNT. 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 24073410 ↗
• MalfunctionDec 15, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE. DURING THE SECOND INFLATION AT 8 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 23812385 ↗
• MalfunctionSep 10, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. 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 23019072 ↗
• MalfunctionFeb 19, 2025Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT CATHETER WAS USED TO TREAT A PERIPHERAL LESION. AFTER BALLOON INFLATION, THE NON-PHILIPS GUIDEWIRE GOT STUCK INSIDE THE PATIENT; THUS, THE CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT CATHETER. 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 21415411 ↗
• MalfunctionOct 29, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A FIBROUS ARTERIOVENOUS FISTULA. DURING THE SECOND INFLATION AT 10 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 20563528 ↗
• MalfunctionMay 22, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE DISTAL RADIAL ARTERY. DURING INFLATION BELOW 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 16974080 ↗
• MalfunctionApr 4, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MID-PERONEAL ARTERY. DURING THE SECOND INFLATION AT 6 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 CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675336 ↗
• MalfunctionMar 21, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID SFA LESION. DURING THE SECOND INFLATION AT 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 16587535 ↗
• MalfunctionNov 2, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID-PERONEAL 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 15715811 ↗
• MalfunctionAug 8, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED MID-SHUNT VESSEL. DURING INFLATION AT 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 15188618 ↗
• MalfunctionAug 8, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED MID-SHUNT VESSEL. DURING INFLATION AT 12 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 15188581 ↗
• MalfunctionFeb 4, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A PERIPHERAL LESION. DURING THE FIRST INFLATION FROM 6 ATM TO 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 13454696 ↗
• MalfunctionOct 23, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A MODERATELY CALCIFIED LESION AND A MODERATELY TORTUOUS VESSEL. DURING THE FIRST INFLATION AT 14 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 10731035 ↗
• MalfunctionAug 13, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED LESION. DURING THE FOURTH INFLATION AT 14 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10405483 ↗