UroMax Ultra Kit M0062251370Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729302438), received between Jan 14, 2020 and Oct 31, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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 4 most recent of 4 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 THIRD OF FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES IN REFERENCE TO MEDWATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441965 ↗
• 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 FIRST OF FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES IN REFERENCE TO MEDWATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441964 ↗
• 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 SECOND OF FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES IN REFERENCE TO MEDWATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441960 ↗
• MalfunctionJan 14, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATATION BALLOON CATHETER DEVICE WAS USED FOR A DILATATION OF THE URINARY PASSAGE PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THE SHAFT WAS SLIGHTLY BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATATION BALLOON CATHETER. THERE HAVE BEEN NO PATIENT COMPLICATIONS 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 9586010 ↗