AngioSculpt OTW PTA Scoring Balloon Catheter 2332-7040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132022198), received between Dec 22, 2019 and Dec 22, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Deflation Problem” (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.

• InjuryDec 22, 2019Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method

  THE ANGIOSCULPT BALLOON WAS INFLATED THREE TIMES UNDER RBP (10-13 ATM) WITH NO ISSUES. PER THE PHYSICIAN, THIS MAY HAVE BEEN USER ERROR SINCE THE BALLOON MAY NOT HAVE BEEN ENTIRELY DEFLATED WHEN HE ATTEMPTED TO WITHDRAW FROM THE PATIENT, UNDER THE BELIEF THAT IT WAS FULLY DEFLATED. SOME CONTRAST MAY HAVE BEEN LEFT IN THE BALLOON, WHICH POSSIBLY RESULTED IN CONTRAST TO GET TRAPPED, THEN ACCUMULATE IN THE BULB OF THE BALLOON DURING RETRACTION. THE PHYSICIAN THEN ATTEMPTED SEVERAL TIMES TO RE-INFLATE THE BALLOON, BUT UNABLE TO DO SO. DURING REMOVAL, THE DEVICE BROKE APART WITHIN THE VESSEL, RESULTING IN THE NEED TO SNARE IT IN ITS ENTIRETY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9508618 ↗