UroMax Ultra M0062251070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729341178), received between Sep 27, 2021 and Nov 5, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A UROMAX ULTRA BALLOON DILATION CATHETER DEVICE WAS SET FOR USE IN A TRANSURETHRAL URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY PROCEDURE. DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON HAD A SMALL HOLE AND WAS LEAKING WATER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED THAT A BALLOON PINHOLE LEAK WAS NOTED APPROXIMATELY 12MM PROXIMAL FROM THE DISTAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475972 ↗
• MalfunctionMay 27, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A TRANSURETHRAL URETEROSCOPIC LASER LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE IT WAS NOTICED THAT IT HAD A SMALL HOLE ON THE CATHETER, AND THE WATER FLOWED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED THAT A BALLOON PINHOLE LEAK WAS NOTED 18MM DISTAL FROM THE PROXIMAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091804 ↗
• MalfunctionJan 8, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS PRE-INFLATED BEFORE THE INSERTION; HOWEVER, THE BALLOON WAS TORN AND DEFLATED IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106939 ↗
• MalfunctionOct 29, 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 URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. REPORTEDLY, THE BALLOON COULD NOT DILATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED BASKET IDENTIFIED THAT A PINHOLE IN THE BALLOON MATERIAL WAS FOUND LOCATED APPROXIMATELY 2MM DISTAL OF THE DISTAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563701 ↗
• MalfunctionSep 27, 2021Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATATION BALLOON CATHETER WAS USED IN THE URETER DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS LEAKING WATER IN TWO DIRECTIONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATATION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 12532121 ↗