AngioSculpt OTW PTA Scoring Balloon Catheter 2092-5040Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00813132021412), received between Jul 10, 2020 and Apr 9, 2026 — classified as 3 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (26 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Material Rupture

  AN ANGIOSCULPT DEVICE WAS USED FOR A PERIPHERAL THERAPEUTIC PROCEDURE IN THE AV SHUNT. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 12 ATM (RBP: 14 ATM). 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 24832739 ↗
• MalfunctionFeb 5, 2026Material Rupture

  AN ANGIOSCULPT DEVICE WAS USED FOR A PERIPHERAL AV SHUNT PROCEDURE IN THE RADIAL ARTERY. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATM (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 24272697 ↗
• MalfunctionMar 28, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE. DURING THE FIRST INFLATION BELOW NOMINAL PRESSURE (8 ATM), THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH THE 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 21719396 ↗
• MalfunctionFeb 20, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE. DURING THE FIRST 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 21426268 ↗
• MalfunctionDec 27, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A CALCIFIED LESION. DURING THE FIRST 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 21030628 ↗
• 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 THE 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 20510919 ↗
• MalfunctionSep 4, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A CALCIFIED PROXIMAL SFA. DURING THE THIRD 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 BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20133320 ↗
• MalfunctionAug 7, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE. DURING THE FIRST 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 19935003 ↗
• MalfunctionJun 27, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MODERATELY CALCIFIED AV FISTULA. 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 19629478 ↗
• MalfunctionMay 3, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID RADIAL VEIN. DURING THE SECOND INFLATION AT 16 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 19243831 ↗
• MalfunctionMay 3, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE SFA ARTERY. DURING INFLATION BELOW NOMINAL PRESSURE, 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 19243726 ↗
• MalfunctionJun 7, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE DISTAL SFA. 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 17083106 ↗
• MalfunctionMar 3, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL SFA. DURING INFLATION AT 12 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 13660381 ↗
• MalfunctionFeb 15, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED PERIPHERAL LESION. DURING THE FIRST INFLATION BEFORE REACHING NOMINAL PRESSURE FOR 4 TO 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 13539031 ↗
• MalfunctionJan 28, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID SFA. DURING THE THIRD 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 13387292 ↗
• MalfunctionJan 13, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID SFA. DURING THE 3RD INFLATION AT 14 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 AT RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13256294 ↗
• InjuryNov 2, 2021Entrapment of Device; Material Rupture; Entrapment of Device; Material Rupture

  A STENT PLACEMENT WAS REQUIRED TO TREAT THE HEMOSTASIS THAT RESULTED WITH THE USE OF THE ANGIOSCULPT DEVICE. THE PATIENT WAS DISCHARGED AS SCHEDULED WITHOUT ISSUES. NO PORTION OF THE DEVICE REMAINED IN THE PATIENT.

  Patient problems: Perforation of Vessels

  MAUDE report 12740890 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A PERIPHERAL LESION ON (B)(6) 2021 WITH NO ISSUES REPORTED. HOWEVER, THE FOLLOWING DAY THE PATIENT EXPERIENCED A THROMBUS OCCLUSION AND EMBOLIZATION IN THE ULNAR ARTERY AND REQUIRED INTERVENTION. THE PATIENT WAS TREATED WITH AN ULTRAVERSE CATHETER WITH NO PATIENT PROBLEM REPORTED.

  Patient problems: Embolism/Embolus; Thrombosis/Thrombus

  MAUDE report 12264339 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A PERIPHERAL LESION ON (B)(6) 2021 WITH NO ISSUES REPORTED. HOWEVER, THE FOLLOWING DAY THE PATIENT EXPERIENCED A THROMBUS OCCLUSION IN THE ULNAR ARTERY AND REQUIRED INTERVENTION. THE PATIENT WAS TREATED WITH A NSE BALLOON.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12264282 ↗
• MalfunctionJun 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE, THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID SFA. DURING THE FIRST INFLATION AT 6 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11936020 ↗
• MalfunctionJun 3, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID CEPHALIC VEIN AND DURING INFLATION, THE BALLOON RUPTURED AT 10 ATM. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935543 ↗
• MalfunctionFeb 1, 2021Material Rupture; Material Rupture

  DURING THE FIRST INFLATION AT 7 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 11263459 ↗
• MalfunctionNov 17, 2020Material Rupture; Material Rupture

  DURING THE FIRST INFLATION AT 7 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH THE SUSPECT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10853992 ↗
• MalfunctionNov 12, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION. DURING THE FIRST INFLATION AT 14 ATM FOR 1 SECOND, 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 10833511 ↗
• MalfunctionNov 4, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SLIGHTLY CALCIFIED AND MODERATELY TORTUOUS DISTAL SFA. DURING THE 8TH INFLATION AT 14 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 10785348 ↗