UroMax Ultra M0062251000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729341109), received between Oct 10, 2018 and Aug 20, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Fluid/Blood Leak

  It was reported that a Uromax Ultra Dilation Balloon Catheter was used during a Ureteroscopy (URS) procedure. During the procedure, it was found that the coil of the tail was broken. Additionally, when the balloon was being inflated, a leak was discovered that prevented it from fully expanding. The procedure was completed with another of the same device with no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50335394 ↗
• MalfunctionFeb 26, 2020Burst Container or Vessel; Material Puncture/Hole; Burst Container or Vessel; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATATION BALLOON CATHETER DEVICE WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER IT WOULD NOT INFLATE. REPORTEDLY, THE BALLOON WAS INSPECTED AND A SMALL HOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATATION BALLOON CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9756169 ↗
• MalfunctionSep 18, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATATION BALLOON WAS USED IN THE KIDNEY, URETER AND BLADDER (KUB) DURING AN URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING INTRODUCTION OF THE DEVICE INTO THE PATIENT, IT WAS NOTED THAT THE BALLOON HAD A LEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATATION BALLOON. 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 OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9081285 ↗
• MalfunctionFeb 7, 2019Leak/Splash; Leak/Splash

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO UROMAX ULTRA DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO UROMAX ULTRA DILATATION BALLOONS WERE USED IN THE URETER DURING A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE FIRST BALLOON BURST. REPORTEDLY, A SECOND BALLOON WAS USED AND THE DEVICE WOULD NOT INFLATE DUE TO A LEAK NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH THE THIRD UROMAX ULTRA DEVICE. 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 Consequences Or Impact To Patient

  MAUDE report 8316523 ↗
• MalfunctionFeb 7, 2019Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO UROMAX ULTRA DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO UROMAX ULTRA DILATATION BALLOONS WERE USED IN THE URETER DURING A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE FIRST BALLOON BURST. REPORTEDLY, A SECOND BALLOON WAS USED AND THE DEVICE WOULD NOT INFLATE DUE TO A LEAK NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH THE THIRD UROMAX ULTRA DEVICE. 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 Consequences Or Impact To Patient

  MAUDE report 8316363 ↗
• MalfunctionJan 30, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATATION BALLOON WAS USED IN THE LEFT URETEROPELVIC JUNCTION DURING A CYSTOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THE BALLOON WAS LEAKING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8289343 ↗
• MalfunctionOct 10, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA URETERAL DILATATION BALLOON WAS USED IN THE RIGHT URETER DURING A URETERAL STRICTURE BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BREAKS UP DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA URETERAL DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7951552 ↗