UroForce® Balloon Dilation Catheter 888504Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741053122), received between Oct 19, 2017 and Sep 2, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2020Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BALLOON COULD NOT BE INFLATED. IT WAS ALSO STATED THAT THE ANOTHER CATHETER WAS USED. AS PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 01DEC2020 FROM INVESTIGATOR, IT WAS FOUND THAT THE BALLOON WAS TORN AND PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 01DEC2020 FROM INVESTIGATOR, AS THE BALLOON COULD NOT BE INFLATED FOR A BALLOON DILATION CATHETER.

  Patient problems: Insufficient Information; No Patient Involvement

  MAUDE report 10483190 ↗
• MalfunctionApr 9, 2020Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT DURING PRETEST, THE BALLOON RUPTURED.

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

  MAUDE report 9942925 ↗
• MalfunctionDec 17, 2019Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER BALLOON BURST DURING PRETEST.

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

  MAUDE report 9480277 ↗
• MalfunctionJan 17, 2019Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER COULD NOT BE INFLATED DURING A PRETEST.

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

  MAUDE report 8257516 ↗
• MalfunctionOct 19, 2017Inflation Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BALLOON WAS NOT INFLATING, AND POWDER WAS SEEN INSIDE THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6960901 ↗