UroMax Ultra M0062251020Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729341123), received between Dec 23, 2019 and Aug 10, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Break; Inflation Problem; Nonstandard Device

  It was reported that a Uromax Ultra Dilation Balloon Catheter was used during a Ureterorenolithotripsy (URSL) procedure. During the procedure, it was found that the coil of the tail was broken and the balloon could not be inflated. The procedure was completed with another of the same device with no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50196975 ↗
• MalfunctionJun 30, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. REPORTEDLY, THE UROMAX BALLOON BROKE DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365294 ↗
• MalfunctionAug 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE UROMAX BALLOON GOT DAMAGED, WHICH LED TO WATER LEAKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATION BALLOON CATHETER DEVICE. 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 STABLE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17545738 ↗
• MalfunctionMar 8, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON WAS USED IN THE KIDNEY DURING A LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, WHEN THE PHYSICIAN OPENED THE UROMAX KIT, IT WAS NOTED THAT THE WIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501229 ↗
• MalfunctionMay 5, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON CATHETER WAS USED IN THE URETEROVESICAL JUNCTION (UVJ) FOR A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6), 2022. DURING PREPARATION, IT WAS NOTED THAT THE BALLOON BROKE WHEN INFLATED TO 20 ATM WITHIN 10 SECONDS OF THE DILATATION PROCESS. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA BALLOON CATHETER. 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 14291248 ↗
• MalfunctionSep 13, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON CATHETER WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE ON AN UNKNOWN DATE. DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON HAD A HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA 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 12459176 ↗
• MalfunctionAug 4, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATATION BALLOON CATHETER WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277146 ↗
• MalfunctionAug 4, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATATION BALLOON CATHETER WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276984 ↗
• MalfunctionMay 6, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATION BALLOON CATHETER WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS NOTICED THAT THE BALLOON HAD A PINHOLE, WHICH WAS CONFIRMED VIA A PHOTO SUBMITTED BY THE CUSTOMER. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. **ADDITIONAL INFORMATION RECEIVED ON MAY 9, 2021** REPORTEDLY, THE DEVICE WAS USED IN THE URETER AND THE PROBLEM WAS NOTICED DURING PREPARATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782618 ↗
• MalfunctionMar 11, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATION BALLOON CATHETER WAS USED IN THE URETER DURING A FLEXIBLE URETEROSCOPY (FURS) PROCEDURE PERFORMED ON (B)(6) 2020. DURING PREPARATION, THE BALLOON WAS TESTED BY INFLATING WATER INTO IT AND IT WAS NOTED THAT THE BALLOON WAS LEAKING AND CAN NOT BE INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATION 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463092 ↗
• MalfunctionDec 23, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATATION BALLOON CATHETER WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON; HOWEVER, THE BALLOON WAS UNABLE TO BE INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATATION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE BALLOON FOUND A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9510908 ↗