AngioSculpt OTW PTA Scoring Balloon Catheter 2155-3040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813132021320), received between Sep 19, 2018 and Nov 12, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED AND SLIGHTLY TORTUOUS PROXIMAL ANTERIOR TIBIAL AND POPLITEAL ARTERY. DURING INFLATION AT 5-6 ATM, BLOOD WAS SEEN IN THE ENDOFLATOR INDICATING A BALLOON RUPTURE OR TEAR. A NEW ANGIOSCULPT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10833505 ↗
• InjuryFeb 28, 2019Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  THE ANGIOSCULPT DEVICE GOT STUCK ON THE GUIDE WIRE IN TRANSIT TO THE LESION; THEREFORE, IT WAS REMOVED AS A SYSTEM. THE PHYSICIAN REWIRED THE LESION AND COMPLETED THE PROCEDURE WITH A NEW ANGIOSCULPT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8377930 ↗
• MalfunctionSep 19, 2018Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  THE ANGIOSCULPT DEVICE RUPTURED WHILE BEING INFLATED AT 18 ATM. THE DEVICE WAS REMOVED WITH NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH A CSI AND 4.5 X 120 MM SUPERA STENT, THEN POST DILATED WITH 4 X 40 MM RAPIDCROSS CATHETER. NOTE: RETURNED PRODUCT INVESTIGATION FOUND THE SCORING ELEMENT RINGS DETACHED FROM THE DISTAL BOND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7890095 ↗