AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating 2249-50200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813132021566), received between Jul 11, 2018 and Apr 24, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL LESION. DURING INFLATION AT 6 ATM (NOMINAL), 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 16801133 ↗
• InjuryJul 15, 2022Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL LESION. UPON REMOVAL, THE DEVICE COULD NOT BE REMOVED THROUGH THE SHEATH, THUS THE DEVICE AND SHEATH WERE REMOVED TOGETHER AS A UNIT. A NEW SHEATH AND NON-ANGIOSCULPT DEVICE WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT IS BEING REPORTED BECAUSE THE ANGIOSCULPT GOT STUCK ON A NON-MANUFACTURER'S INTRODUCER SHEATH AND WERE REMOVED AS A UNIT. PLACEMENT OF A NEW SHEATH WAS NECESSARY TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033772 ↗
• InjuryJul 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ANGIOSCULPT BALLOON WAS INSERTED OVER A .014" E S"PORT GUIDE WIRE AND RESISTANCE WAS NOTED TRACKING TO THE LESION. THE BALLOON WAS INFLATED TO 6 ATM FOR 3 MIN. THE BALLOON WAS DEFLATED AND ATTEMPTED TO REMOVE FROM THE BODY. DURING REMOVAL IT WAS DISCOVERED THAT A KINK IN THE WIRE HAD APPEARED AND BECAME DIFFICULT TO REMOVE. WHEN THE SCORING ELEMENT OF THE BALLOON ENGAGED THE 6F SHEATH, IT BECAME MORE DIFFICULT TO PULL OUT. WHILE ATTEMPTING TO REMOVE, THE DISTAL SHAFT BROKE. THE BALLOON AND SCORING ELEMENT BECAME TRAPPED IN THE DISTAL PORTION OF THE SHEATH. THE PATIENT WAS SENT TO SURGERY TO REMOVE THE REMAINING DEVICE FROM THE PATIENT'S LEG.

  Patient problems: Atherosclerosis; Peripheral Vascular Disease

  MAUDE report 7677490 ↗