UroMax Ultra M0062251040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729341147), received between Mar 1, 2023 and Apr 22, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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.

• MalfunctionApr 22, 2024Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING THE PROCEDURE THE BALLOON WAS INSERTED AND ATTEMPTED TO INFLATE; HOWEVER, THE BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160673 ↗
• MalfunctionMar 1, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON DILATATION CATHETER WAS USED DURING A BLADDER NECK STRICTURE TREATMENT PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST WHEN INFLATED TO 13 MILLIBAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460219 ↗