UroForce® Balloon Dilation Catheter 887404Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801741052948), received between May 24, 2018 and May 24, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2018Burst Container or Vessel

  IT WAS REPORTED THAT THE UROFORCE CATHETER BALLOON WAS INSERTED AND INFLATED TO 4 ATM USING THE EAGLE INFLATION DEVICE. IT WAS REPORTED THAT THE PHYSICIAN THEN ASKED THE NURSE TO INFLATE THE CATHETER BALLOON TO 8 ATM, AT WHICH TIME THE NURSE BEGAN TO USE THE EAGLE INFLATION DEVICE TO INCREASE THE PRESSURE IN THE BALLOON. IT WAS REPORTED THAT, WHEN THE PRESSURE GOT TO 5 ATM, THE BALLOON OF THE CATHETER BURST. IT WAS REPORTED THAT THERE WERE NO MISSING PIECES; HOWEVER, THE PATIENT'S URETER "RUPTURED," AND A STENT WAS PLACED TO ALLOW THE AREA TO HEAL.

  Patient problems: No Known Impact Or Consequence To Patient; Rupture

  MAUDE report 7541989 ↗