AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating 2290-40100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132022938), received between Aug 10, 2022 and Aug 10, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Sharp Edges” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2022Sharp Edges; Sharp Edges

  THE ANGIOSCULPT DEVICE WAS USED IN THE MID SFA. DURING REMOVAL, RESISTANCE WAS NOTED AND THE DEVICE WAS KNOTTED AT THE VESSEL SITE. WITH MUCH FORCE APPLIED, THE DEVICE WAS ABLE TO BE REMOVED BUT THE PATIENT EXPERIENCED A LOT OF PAIN. UPON REMOVAL, THE SCORING ELEMENT WAS KNOTTED AND ONE SCORING ELEMENT STRUT DETACHED, BUT REMAINED INTACT. THE PROCEDURE WAS COMPLETED WITH A PLAIN BALLOON. UNDER ANGIOGRAPHY, NO DAMAGE TO THE VESSEL WAS OBSERVED. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE DETACHED SCORING ELEMENT STRUT RESULTING IN A SHARP EDGE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: Pain

  MAUDE report 15200152 ↗