AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating 2216-25100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132022907), received between Jun 9, 2021 and Jun 11, 2024 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2024Deflation Problem; Deflation Problem

  THE ANGIOSCULPT CATHETER WAS USED TO TREAT A SLIGHTLY PLAQUE DISTAL ANTERIOR TIBIAL ARTERY. AFTER INFLATION TO 8 ATM, THE BALLOON WAS UNABLE TO DEFLATE. AN ACCESS NEEDLE WAS USED TO PUNCTURE THE BALLOON THROUGH THE SKIN IN ORDER TO DEFLATE THE BALLOON. A 2.0 ARMADA DEVICE WAS USED TO TAMPONADE THE AREA OF THE PUNCTURE SITE. THE PROCEDURE WAS COMPLETED WITH THE ANGIOSCULPT CATHETER. THERE WAS NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM AND ADVERSE EVENT IS BEING SUBMITTED DUE TO THE BALLOON DEFLATION ISSUE, REQUIRING ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510995 ↗
• MalfunctionJun 9, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID AT. DURING INFLATION AT 16 ATM FOR 2 MINUTES, THE BALLOON DEFLATED AND RUPTURED. A NEW ANGIOSCULPT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971442 ↗