AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating 2237-50100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132022839), received between May 13, 2020 and May 13, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• InjuryMay 13, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PHYSICIAN INSERTED A 5F INTRODUCER SHEATH IN THE PATIENT¿S LEFT GROIN AND DIRECTED TOWARDS THE RIGHT DISTAL SFA TO TREAT A STENOTIC CALCIFIED LESION. THEN AN ANGIOSCULPT DEVICE WAS INSERTED THROUGH THE INTRODUCER SHEATH AND THE BALLOON WAS INFLATED AND DEFLATED WITH NO ISSUES. DURING WITHDRAWAL, THE ANGIOSCULPT GOT CAUGHT IN THE INTRODUCER SHEATH AND COULD NOT BE REMOVED. THE PHYSICIAN CUT THE PROXIMAL SHAFT AND INTRODUCER SHEATH TOGETHER FOR REMOVAL, BUT DECIDED TO PULL THE ANGIOSCULPT, INTRODUCER SHEATH, AND GUIDE WIRE AS A SYSTEM. COMPLETION OF THE ANGIOGRAM CONFIRMED NO RETAINED PARTS OF THE ANGIOSCULPT OR INTRODUCER SHEATH WAS LEFT IN THE PATIENT. UPON REMOVAL, THE BALLOON APPEARED TO NOT HAVE FULLY DEFLATED AND CONTRAST WAS NOTED INSIDE THE BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10054330 ↗