UroMax Ultra M0062251180Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729341260), received between Oct 26, 2022 and Oct 26, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2022Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON DILATATION CATHETER WAS USED IN THE RIGHT URETER DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THERE WAS AN OBSTRUCTION IN THE MIDDLE OF THE CATHETER AND THE GUIDEWIRE WOULD NOT ENTER. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA BALLOON DILATATION CATHETER. NOTE: A PHOTO WAS SUBMITTED BY THE CUSTOMER SHOWING THAT THE CATHETER WAS KINKED AT THE MIDDLE SECTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672540 ↗