AngioSculpt OTW PTA Scoring Balloon Catheter 2092-4040Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00813132021405), received between Jun 28, 2018 and Jan 23, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Entrapment of Device

  THE ANGIOSCULPT CATHETER WAS USED IN A PERIPHERAL PROCEDURE. DURING REMOVAL, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, NECESSITATING SIMULTANEOUS WITHDRAWAL OF THE ANGIOSCULPT WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. 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 24167123 ↗
• MalfunctionSep 14, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID SHUNT. 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. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15423929 ↗
• MalfunctionJul 15, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL LESION. THE BALLOON WAS INFLATED TO 10 ATM FOR 30 SECONDS WITH NO ISSUES. THEN, THE BALLOON WAS PRESSURIZED TO 14 ATM BUT THE VALUE ON THE INDEFLATOR DID NOT GO UP DUE TO A RUPTURE. THE PROCEDURE WAS COMPLETED WITH A NON-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 15033608 ↗
• MalfunctionDec 28, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A PERIPHERAL LESION. DURING THE 2ND OR 3RD 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 13102068 ↗
• MalfunctionFeb 4, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED SFA. DURING THE SECOND INFLATION AT 4 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 11279176 ↗
• MalfunctionDec 22, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED AND SEVERELY TORTUOUS MID SFA. DURING THE SECOND INFLATION AT 12 ATM, 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 11060590 ↗
• MalfunctionDec 17, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION. DURING THE SECOND 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 11032936 ↗
• MalfunctionDec 17, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED AND SEVERELY TORTUOUS SFA. DURING THE FIRST INFLATION AT 14 ATM FOR 1 MINUTE, 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 11032898 ↗
• MalfunctionAug 31, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A VASCULAR ACCESS INTERVENTION THERAPY (VAIVT). 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 10472205 ↗
• MalfunctionJul 22, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A MODERATELY CALCIFIED POPLITEAL, P2. DURING THE FIRST INFLATION AT 4-6 ATM, THE BALLOON RUPTURED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311725 ↗
• MalfunctionJul 10, 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 POPLITEAL, P2. THE BALLOON WAS INFLATED QUICKLY ABOVE THE RATED BURST PRESSURE (RBP) WHEN THE BALLOON RUPTURED. THE USER WAS AWARE THAT THE DEVICE WAS USED OUTSIDE OF THE IFU.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10261496 ↗
• MalfunctionNov 29, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING THE THIRD INFLATION AT 16 ATM FOR 30 SECONDS, THE BALLOON RUPTURED. A CUTTING BALLOON CATHETER WAS ALTERNATIVELY USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8115033 ↗
• MalfunctionJun 28, 2018Burst Container or Vessel; Burst Container or Vessel

  Patient problems: Atherosclerosis; Peripheral Vascular Disease

  MAUDE report 7647326 ↗