Ultraverse® 035 PTA Dilatation Catheter U357598Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741094361), received between May 5, 2017 and Dec 2, 2022 — classified as 3 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2022Difficult to Insert; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Insert; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON DILATATION CATHETER ALLEGEDLY DIFFICULT TO INSERT AND HAD DEVICE INCOMPATIBILITY ISSUES. IT WAS FURTHER REPORTED THAT THE BALLOON CANNOT GET OUT FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902977 ↗
• MalfunctionAug 18, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A LEFT BASILIC FISTULA, THE PTA BALLOON CATHETER ALLEGEDLY HAD DIFFICULTY BEING DEFLATED AFTER BEING INFLATED TO 12 ATM ON THE THIRD INFLATION ATTEMPT. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6805145 ↗
• MalfunctionMay 5, 2017Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A TIGHT LESION OF A FOREARM FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED PAST THE RATED BURST PRESSURE. REPORTEDLY, ONE OF THE MARKER BANDS DETACHED FROM THE BALLOON AFTER THE RUPTURE OCCURRED. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER SUCCESSFULLY REMOVED THE MARKER BAND FROM THE PATIENT. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6549420 ↗