Ultraverse® 014 U4150422Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741064531), received between Jan 17, 2022 and Aug 21, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• InjuryAug 21, 2023Entrapment of Device; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LOWER EXTREMITY ARTERIES, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AFTER TWO MINUTES OF INFLATION. IT WAS FURTHER REPORTED THAT WHILE PASSING THROUGH THE INTRODUCER INTO THE COMMON FEMORAL ARTERY, THE BALLOON WAS ALLEGEDLY BROKEN INTO SEVERAL PIECES REQUIRING THE REMOVAL OF THE GUIDE INTRODUCER TO REMOVE THE BALLOON SEGMENTS. HOWEVER, SOME BALLOON PIECES REPORTEDLY REMAINED WITHIN THE REMNANT COMMON FEMORAL ARTERY OF THE DISTAL BALLOON CORRESPONDING TO THE TWO TERMINAL MARKERS. REPORTEDLY, THE PHYSICIAN INCISED THE SKIN AROUND THE FEMORAL ARTERIAL ACCESS TO FACILITATE THE RECOVERY OF THE RESIDUAL PIECES AND AN INTRODUCER GUIDE WAS POSITIONED THROUGH WHICH A BALLOON WAS INFLATED DOWNSTREAM OF THE RESIDUES, WHICH WAS WITHDRAWN AND PARTIALLY REMOVED THROUGH THE INTRODUCER. APPARENTLY, THE DISTAL BALLOON MARKER REMAINS IN THE SUPERFICIAL FEMORAL ARTERY WALL. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 17584413 ↗
• MalfunctionJan 17, 2022Material Rupture; Detachment of Device or Device Component; Packaging Problem; Material Rupture; Detachment of Device or Device Component; Packaging Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED UPON PULLING IT OUT OF THE HOOP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13263292 ↗