UroForce® Balloon Dilation Catheter 887504Recalls & reported problems
C. R. Bard, Inc. · UroForce® Balloon Dilation Catheter · Class 2
All models of UroForce Balloon Dilation Catheter (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801741052979), received between Aug 30, 2017 and May 13, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel3
- Material Rupture2
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
- Patient Problem/Medical Problem1
- Tissue Damage1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT CUSTOMER BELIEVED THE TM STATED THE BALLOON DILATION CATHETER BURST ON A PREVIOUS USE AND SUBMITTED TO COMPLAINTS, BUT THEY WANTED TO SHARE JUST IN CASE. UROFORCE BALLOON DILATION CATHETERS WERE RECOMMENDED FOR DILATION OF THE URINARY TRACT. THIS WOULD BE CONSIDERED OFF LABEL. DISCUSSED HOW THE XFORCE N30 CATHETERS WERE RECOMMENDED FOR USE IN THE DILATION OF THE NEPHROSTOMY TRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22009540 ↗InjuryFeb 28, 2019Burst Container or Vessel; Material Rupture; Burst Container or Vessel
IT WAS REPORTED THAT THE BALLOON OF THE CATHETER BURST. THE PATIENT'S URETER WAS DAMAGED AND REQUIRED TEMPORARY STENTING.
Patient problems: Patient Problem/Medical Problem; Tissue Damage
MAUDE report 8378347 ↗MalfunctionDec 5, 2017Burst Container or Vessel
IT WAS REPORTED THAT THE BALLOON OF THE CATHETER BURST, AND NO PIECES OF THE BALLOON WERE MISSING. ALLEGEDLY, THE DEVICE WAS USED WITH A CYSTOSCOPE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7082107 ↗MalfunctionAug 30, 2017Burst Container or Vessel
IT WAS REPORTED THAT THE BALLOON OF THE CATHETER BURST. IT WAS REPORTED THAT NO PIECES OF THE BALLOON WERE MISSING UPON REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6829470 ↗
Other DILATOR, CATHETER, URETERAL devices
- Porges Coloplast RBD014Coloplast A/S · DILATOR, CATHETER, URETERAL1 recall0 reports
- Bard® X-Force® Balloon Dilation Catheter 998706C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL38 reports
- Bard® X-Force® Balloon Dilation Catheter 998606C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL27 reports
- Bard® X-Force® Balloon Dilation Catheter 998006C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL25 reports
- Bard® X-Force® Balloon Dilation Catheter 998806C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL23 reports
- Bard® X-Force® Balloon Dilation Catheter 998504C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL16 reports
- Bard® X-Force® Balloon Dilation Catheter 998004C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL15 reports
- Bard® X-Force® Balloon Dilation Catheter 998506C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL15 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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