AngioSculpt OTW PTA Scoring Balloon Catheter 2076-6020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132021382), received between Mar 8, 2022 and Mar 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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.

• MalfunctionMar 8, 2022Material Rupture; Material Rupture

  THE ANGIOSULPT DEVICE WAS USED TO TREAT A PERIPHERAL LESION. DURING THE FIRST INFLATION BELOW RBP, THE BALLOON DID NOT INFLATE. UPON REMOVAL OUTSIDE OF THE PATIENT'S BODY, A LEAK FROM THE TIP WAS OBSERVED, BUT COULD NOT CONFIRM EXACT LOCATION OF THE LEAK. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON MAY HAVE RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13689454 ↗