Ultraverse® 035 PTA Dilatation Catheter U357592Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741094330), received between Jul 24, 2017 and Jul 25, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2018Difficult to Insert; Retraction Problem; Difficult to Insert; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO INSERT THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE PTA BALLOON HAD DIFFICULTY RETRACTING THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7719441 ↗
• MalfunctionJul 24, 2017Difficult to Insert; Kinked; Retraction Problem; Difficult to Insert; Kinked; Retraction Problem

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE BALLOON CATHETER THROUGH A 6 FR SHEATH, STRONG RESISTANCE WAS MET AND THE CATHETER ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER (HCP) ATTEMPTED TO REMOVE THE BALLOON CATHETER ONLY, BUT INSTEAD REMOVED THE CATHETER, SHEATH, AND GUIDEWIRE AS A SINGLE UNIT, LOSING ACCESS ACROSS THE LESION. REPORTEDLY, THE HCP USED ANOTHER GUIDEWIRE, SHEATH, AND BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6737054 ↗