Ultraverse® 035 PTA Dilatation Catheter U3513054Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741092671), received between Jan 15, 2020 and May 14, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19307661 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST AN ANGIOPLASTY PROCEDURE, THE FEMORAL ARTERY, POPLITEAL ARTERY AND DORSALIS PEDIS ARTERY OF THE LEFT LOWER LIMB OF THE PATIENT ALLEGEDLY HAD NO PULSATION, A LARGE AREA OF PIEBALD-LIKE CHANGES, AND LOW SKIN TEMPERATURE. IT WAS FURTHER REPORTED THAT THROUGH DOPPLER ULTRASOUND EXAMINATION OF THE ARTERIES AND VEINS, THE PATIENT ALLEGEDLY EXPERIENCED MASSIVE THROMBOSIS IN THE ARTERIES OF THE LEFT LOWER EXTREMITY AND AN EMERGENCY ARTERIOTOMY AND EXPLORATORY THROMBECTOMY OF THE LEFT LOWER EXTREMITY ARTERIES WAS PERFORMED.. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18423806 ↗
• MalfunctionDec 9, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF THE LOWER LIMB THROUGH THE RIGHT FEMORAL ARTERY, THE DEVICE ALLEGEDLY FAILED TO INFLATE CAUSING LEAKAGE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12966007 ↗
• MalfunctionJan 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U3513054 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9594072 ↗