UroMax Ultra Kit M0062251210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729341284), received between Jul 26, 2017 and Dec 23, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 5, 2025Class IIOpen, Classified

   The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.

   Z-2536-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A URETEROSCOPY (URS), STRICTURE DILATION PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS NOT INFLATING. REPORTEDLY, UPON REMOVAL IT WAS FOUND THAT CONTRAST SOLUTION WAS LEAKING OUT FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877655 ↗
• MalfunctionFeb 28, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATION BALLOON CATHETER WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATION 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 13618399 ↗
• MalfunctionFeb 4, 2020Burst 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 URETER DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED AFTER BEING INFLATED THE THIRD TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9664283 ↗
• MalfunctionMay 23, 2019Burst 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 URETER DURING A UTEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8637930 ↗
• MalfunctionApr 30, 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, IT WAS NOTICED THAT THE BALLOON HAD A HOLE WHEN TRIED TO BE INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATATION BALLOON CATHETER DEVICE. 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 8566328 ↗
• MalfunctionJul 26, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON KIT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, WHILE UNPACKING THERE WAS A HAIR FOUND INSIDE OF THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA BALLOON KIT. 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 UNHARMED AND STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6743678 ↗