AngioSculpt OTW PTA Scoring Balloon Catheter 2076-4020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132021344), received between Oct 13, 2020 and Dec 28, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 28, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SLIGHTLY CALCIFIED PERIPHERAL LESION. AFTER INFLATION AND DURING REMOVAL, RESISTANCE WAS ENCOUNTERED, AND THE SCORING ELEMENT SEPARATED FROM THE BALLOON. THE BALLOON AND GUIDE WIRE WERE REMOVED AS A UNIT. THE SCORING ELEMENT WAS REMOVED USING A RADIAL JAW AND CONFIRMED BY ECHO THAT NO DEVICE FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT CATHETER. THE PATIENT EXPIRED THE FOLLOWING DAY; HOWEVER PER THE PHYSICIAN, THE PATIENT DEATH WAS UNRELATED TO THE ANGIOSCULPT CATHETER. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE SCORING ELEMENT SEPARATION REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13099430 ↗
• MalfunctionOct 13, 2020Material Rupture; Material Rupture

  THE ANGIO-SCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED AND SEVERELY TORTUOUS MID SFA. DURING THE SECOND INFLATION AT 12 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIO-SCULPT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10671650 ↗