AngioSculpt OTW PTA Scoring Balloon Catheter 2076-4040Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00813132021351), received between Dec 7, 2018 and Dec 21, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2025Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT DEVICE WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED MID SFA. DURING INFLATION AT 10 ATM (RBP: 14 ATM), THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. DURING THE RETURN PRODUCT EVALUATION, NO BALLOON LEAK WAS OBSERVED; HOWEVER, THE ANGIOSCULPT WAS INTACT TO AN .014 GUIDEWIRE. PER ADDITIONAL INFORMATION RECEIVED, THE ANGIOSCULPT CAME OUT TOGETHER WITH THE GUIDEWIRE. 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 23860490 ↗
• 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 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 17081269 ↗
• MalfunctionJul 26, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID SFA. DURING THE SECOND INFLATION AT 14 ATM FOR 20 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 AT RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108306 ↗
• MalfunctionMay 17, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A CALCIFIED DISTAL SFA. DURING THE FIRST INFLATION AT 10 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A CUTTING 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 14417832 ↗
• MalfunctionMay 4, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED AND DURING THE FIRST INFLATION AT 8 ATM FOR 5 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 11773819 ↗
• InjuryDec 7, 2018Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  THE ANGIOSCULPT DEVICE WAS USED TOGETHER WITH A RIKISHI GUIDING SHEATH TO TREAT THE SFA. UPON REMOVAL OF THE DEVICE, IT GOT STUCK INSIDE THE GUIDING SHEATH AND THE SCORING ELEMENT PARTIALLY DETACHED FROM THE BALLOON. THE DEVICE AND THE GUIDING SHEATH WERE REMOVED AS A UNIT FROM THE PATIENT WITH NO INJURY. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8143883 ↗