AngioSculpt OTW PTA Scoring Balloon Catheter 2076-5040Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00813132021375), received between Aug 9, 2019 and Jul 1, 2026 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (27 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Entrapment of Device

  THE ANGIOSCULPT CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED MID SFA. DURING USE, THE ANGIOSCULPT BECAME STUCK AT THE LESION SITE AND COULD NOT BE REMOVED. THEREFORE, IT WAS SUBSEQUENTLY WITHDRAWN TOGETHER WITH THE GUIDEWIRE, ALLOWING SUCCESSFUL REMOVAL OF THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER WITH 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 25684175 ↗
• MalfunctionFeb 6, 2026Material Rupture

  AN ANGIOSCULPT CATHETER WAS USED FOR A THERAPEUTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED MID SFA. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 12 ATM (RBP: 14 ATM). THE PROCEDURE WAS COMPLETED WITH A NEW 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 24283860 ↗
• MalfunctionNov 24, 2025Material Rupture; Material Rupture

  AN ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED MID SFA. DURING INFLATION, THE BALLOON RUPTURED BELOW RBP (RBP: 14 ATM). THE PROCEDURE WAS COMPLETED WITH A NEW 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 23638140 ↗
• MalfunctionJul 9, 2025Material Rupture; Material Rupture

  AN ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE. DURING INFLATION, THE BALLOON RUPTURED BELOW RBP (14 ATM). 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 22459699 ↗
• MalfunctionNov 5, 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 THE SAME 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 20614614 ↗
• MalfunctionJun 27, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE DISTAL SFA ARTERY. DURING THE FIRST INFLATION AT 2 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 19628388 ↗
• MalfunctionMar 13, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID-ILIAC ARTERY. DURING THE FIRST INFLATION AT 5 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 18899477 ↗
• MalfunctionJan 26, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID SFA. DURING THE FOURTH 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 18587892 ↗
• MalfunctionJan 17, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED DISTAL SFA. DURING THE FIRST INFLATION AT 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 18530249 ↗
• MalfunctionMar 21, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE ILLIAC ARTERY. DURING THE FIRST INFLATION BELOW 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 16587691 ↗
• MalfunctionJul 7, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN THE MID SFA LESION. DURING THE FIRST INFLATION BELOW 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 BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951689 ↗
• MalfunctionJun 2, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED MID ILIAC. DURING THE 3RD INFLATION AT 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 AT RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14582047 ↗
• MalfunctionDec 28, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL LESION. DURING THE 3RD INFLATION AT 14 ATM FOR 15 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 AT RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13102074 ↗
• MalfunctionDec 28, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID ILIAC. DURING THE 4TH INFLATION, THE BALLOON RUPTURED AT 14 ATM. 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 AT RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101352 ↗
• MalfunctionNov 15, 2021Material Rupture; Material Rupture

  THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817385 ↗
• MalfunctionOct 25, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL SFA. DURING THE 6TH 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 12690029 ↗
• MalfunctionSep 7, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID SFA. DURING INFLATION, THE BALLOON RUPTURED AT 13 BAR. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE BALLOON BURST SEMI-RADIALLY BELOW RBP. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434730 ↗
• MalfunctionAug 19, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED MID SFA. DURING THE FIRST INFLATION BEFORE REACHING NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED USING 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 12345339 ↗
• MalfunctionJul 1, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A PERIPHERAL LESION. DURING INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104275 ↗
• MalfunctionJun 23, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12052607 ↗
• InjuryMay 21, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE, THE ANGIOSCULPT BALLOON WAS INSERTED OVER AN 0.014" GUIDE WIRE AND INFLATED AT NOMINAL PRESSURE DILATING THE LESION 5 TIMES. IN ORDER TO PLACE A STENT, GUIDE WIRE WAS EXCHANGED FROM AN 0.014" TO AN 0.018". HOWEVER DURING REMOVAL OF THE 0.014" GUIDE WIRE, RESISTANCE WAS NOTED, BUT ABLE TO BE REMOVED ALONE. THEN, DURING INSERTION OF THE ANGIOSCULPT BALLOON OVER THE 0.018" GUIDE WIRE, STRONG RESISTANCE WAS ENCOUNTERED AT THE HUB AND WAS UNABLE TO BE INSERTED, THUS WERE REMOVED AS A UNIT. AFTER REMOVAL, THE 0.018" GUIDE WIRE WAS RE-INSERTED AND THE PROCEDURE WAS COMPLETED WITH A STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864171 ↗
• MalfunctionMay 3, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE DISTAL SFA. DURING INFLATION BELOW NOMINAL PRESSURE (8 ATM), 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 11761356 ↗
• MalfunctionApr 21, 2021Material Rupture; Material Rupture

  DURING THE 1ST INFLATION AT NOMINAL PRESSURE (8 ATM) FOR 20 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 11701178 ↗
• MalfunctionFeb 16, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE DISTAL SFA. DURING THE SECOND INFLATION BELOW RBP, 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 11334890 ↗
• MalfunctionDec 17, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED AND SEVERELY TORTUOUS DISTAL SFA. DURING THE SECOND INFLATION AT 12ATM, 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 11033180 ↗