UroForce® Balloon Dilation Catheter 888604Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741053153), received between Jan 12, 2021 and Jun 19, 2024 — classified as 3 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
- Inflation Problem1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THERE WAS LEAKAGE IN BALLOON DILATION CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19567011 ↗MalfunctionOct 11, 2023Inflation Problem; Inflation Problem
IT WAS REPORTED THAT THE CUSTOMER HAD A DEFECTIVE BALLOON DILATION CATHETER THAT WOULD NOT INSUFFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17912244 ↗MalfunctionJan 12, 2021Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE BALLOON DILATION CATHETER WAS INFLATED ABOUT 15ATM, AND THE BALLOON GOT BURST. IT WAS REPLACED WITH NEW PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11154967 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page