UroMax Ultra M0062251170Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729341253), received between Oct 30, 2019 and Apr 10, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Failure to Deflate

  IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED IN A PROCEDURE. REPORTEDLY, THE BALLOON DEVICE WAS INFLATED AS INTENDED; HOWEVER, IT DID NOT DEFLATE. THE DEVICE WAS WITHDRAWN WHILE STILL IN AN EXPANDED STATE WITHIN THE URETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839696 ↗
• MalfunctionJun 14, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON DILATION CATHETER DEVICE WAS USED IN THE BLADDER AND URETER DURING A LEFT URETEROSCOPY WITH LASER LITHOTRIPSY, CYSTOSCOPY WITH LEFT URETERAL STENT REMOVAL, POSSIBLE LEFT URETERAL STENT PLACEMENT AND LEFT RETROGRADE PYELOGRAM PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN NOTED AN UNEXPECTED CONTRAST IN THE URETER AROUND BALLOON AND THE ENCORE DEVICE NO LONGER HELD PRESSURE. THE PROCEDURE WAS ABORTED WITHOUT COMPLETING ALL THE PLANNED PARTS DUE TO THIS EVENT. IT WAS REPORTED THAT THE BALLOON APPEARED INTACT DURING INITIAL EXAMINATION. THE BALLOON WAS THEN RE-EXAMINED, AND IT WAS IDENTIFIED THAT THE BALLOON HAD A PINPOINT HOLE WHEN PRESSURE WAS APPLIED. A MULTI-LENGTH URETERAL STENT WAS PLACED FOR PASSIVE DILATION, AND THE PATIENT WILL HAVE TO RETURN FOR ANOTHER SURGICAL PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124189 ↗
• MalfunctionOct 3, 2022Burst Container or Vessel; Material Deformation; Burst Container or Vessel; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATATION BALLOON CATHETER WAS USED IN THE KIDNEY DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON WAS INFLATED ONCE; HOWEVER, THE BALLOON RUPTURED WHEN IT WAS INFLATED FOR THE SECOND TIME AT 20 ATM. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATION BALLOON CATHETER. NOTE: A PHOTO SUBMITTED BY THE CUSTOMER SHOWS THE BALLOON WAS BURST AND THE CATHETER WAS KINKED AT THE MIDDLE SECTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527452 ↗
• MalfunctionMay 20, 2021Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATION BALLOON CATHETER WAS USED IN THE RIGHT URETER DURING AN URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE LUER LOCK OF THE BALLOON WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATION BALLOON CATHETER. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THIS BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854563 ↗
• MalfunctionOct 30, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATATION BALLOON CATHETER WAS USED IN THE LEFT URETER DURING AN ENDOSCOPIC URETERAL STRICTURE BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST WHEN THE PRESSURE GRADUALLY INCREASED. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATATION BALLOON CATHETER. 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 Consequences Or Impact To Patient

  MAUDE report 9255997 ↗