UroMax Ultra Kit M0062251220Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729341291), received between Feb 19, 2019 and Oct 31, 2025 — classified as 5 malfunctions.

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

• MalfunctionOct 31, 2025Material Rupture; Device Contamination with Chemical or Other Material; Material Rupture; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES WERE SET FOR USE IN A PROCEDURE. HOWEVER, FOREIGN BODIES WERE FOUND INSIDE THE ENCORE INFLATION DEVICES OF THE UROMAX ULTRA BALLOON KIT. ADDITIONALLY, THE UROMAX ULTRA BALLOON DEVICES WERE ALSO NOTED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE FOURTH OF FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES IN REFERENCE TO MEDWATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441968 ↗
• MalfunctionNov 20, 2023Unsealed Device Packaging; Device Contaminated During Manufacture or Shipping; Unsealed Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS ABOUT TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, UPON OPENING OF THE PACKAGE IT WAS FOUND THAT THE ANCHOR INFLATOR STERILIZATION WAS OPEN AND NOT CLEAN. THE PROCEDURE WAS STILL COMPLETED WITH ANOTHER UROMAX ULTRA DILATION BALLOON CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177632 ↗
• MalfunctionFeb 3, 2023Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NUROMAX ULTRA KIT WITH ENCORE 26 INFLATOR WAS USED IN THE KIDNEY DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PROTECTIVE SLEEVE OF THE BALLOON WAS DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NUROMAX ULTRA DILATION BALLOON. 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 SHAFT KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292662 ↗
• MalfunctionJul 6, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX DILATATION BALLOON CATHETER WAS USED IN THE URETER DURING A BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAD A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10232666 ↗
• MalfunctionFeb 19, 2019Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATATION BALLOON WAS USED DURING A STONE EXTRACTION PROCEDURE PERFORMED LAST (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE DEVICE POUCH WAS TORN WHILE OPENING THE PACKAGE AND THE STERILE SEAL WAS COMPROMISED. REPORTEDLY, THIS MIGHT BE DUE TO MANUFACTURE DEFECT. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8350670 ↗