Ultraverse® 035 PTA Dilatation Catheter U35130515Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741092725), received between Apr 15, 2019 and Jan 28, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL OF A NON-COMMERCIALLY AVAILABLE DEVICE, BD LOW PROFILE VASCULAR COVERED STENT (LPVCS). THE SUBJECT UNDERWENT TARGET LESION INTERVENTION ON THE SUPERFICIAL FEMORAL ARTERY IN THE LEFT LIMB USING A COMMERCIALLY AVAILABLE ULTRAVERSE BALLOON WHEN AN ADVERSE EVENT OF VESSEL DISSECTION OCCURRED. THE SEVERITY AND ADVERSE EVENT RELATIVITY WITH THE DEVICE OR PROCEDURE WERE NOT REPORTED. THE LESION WAS STENTED.

  Patient problems: Vascular Dissection

  MAUDE report 24197606 ↗
• MalfunctionApr 10, 2025Difficult to Remove; Stretched; Device-Device Incompatibility; Difficult to Remove; Stretched; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE OVER THE WIRE AND THEN THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT IT WAS INFLATED AND THEN DEFLATED COMPLETELY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21812149 ↗
• MalfunctionDec 12, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20911649 ↗
• MalfunctionOct 18, 2022Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Difficult to Insert; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY IN THE DISTAL SFA, THE BALLOON ALLEGEDLY HAD DIFFICULTY IN INTRODUCING TO THE SHEATH . IT WAS FURTHER REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621955 ↗
• MalfunctionOct 21, 2020Material 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 10712010 ↗
• MalfunctionApr 15, 2019Packaging Problem; Packaging Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U5130515 PTA BALLOON DILATATION CATHETER ALLEGEDLY HAD A PACKAGING ISSUE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THERE WAS NO REPORTED PATIENT CONTACT WITH THE DEVICE AND PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8516616 ↗