Ultraverse® 035 PTA Dilatation Catheter U35130615Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741093227), received between Aug 20, 2018 and Oct 15, 2024 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL THAT DURING PRE-DILATATION OF THE LEFT LEG TARGET LESION STENOSIS ON THE SUPERFICIAL FEMORAL ARTERY USING ULTRAVERSE BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF DISSECTION. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO THE STUDY DEVICE BUT CAUSAL RELATIONSHIP TO THE STUDY PROCEDURE. THE OUTCOME OF THE ADVERSE EVENT WAS RECOVERED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 20450305 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL THAT DURING PRE-DILATATION OF THE LEFT LEG TARGET LESION STENOSIS ON THE SUPERFICIAL FEMORAL ARTERY USING ULTRAVERSE BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF DISSECTION. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO THE STUDY DEVICE BUT CAUSAL RELATIONSHIP TO THE STUDY PROCEDURE. THE OUTCOME OF THE ADVERSE EVENT WAS RECOVERED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 20277514 ↗
• 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 15624733 ↗
• MalfunctionApr 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U35130615 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCE MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965230 ↗
• MalfunctionAug 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED LESION IN THE ILIAC ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED ON THE SECOND INFLATION ATTEMPT PRIOR TO REACHING RATED BURST PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799644 ↗