UroForce® Balloon Dilation Catheter 887604Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801741053006), received between Jun 13, 2017 and Feb 24, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
Device problems
- Detachment Of Device Component1
- Inflation Problem1
- Partial Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2022Partial Blockage; Inflation Problem; Partial Blockage; Inflation Problem
IT WAS REPORTED THAT THE DILATION CATHETER BALLOON WAS MALFUNCTIONING. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 01-FEB-2022, IT WAS REPORTED THAT THE DILATION CATHETER BALLOON WOULD NOT INFLATE. CUSTOMER STATED THAT NO MEDICAL CONCERNS RELATED TO THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13596354 ↗MalfunctionJun 13, 2017Detachment Of Device Component
IT WAS REPORTED THAT A PIECE OF THE CATHETER BALLOON CAME OFF IN THE PATIENT DURING SURGERY. THE COMPLAINANT ALLEGES THAT THE PIECE WAS REMOVED BEFORE SURGERY WAS COMPLETED. NO PATIENT INJURY WAS REPORTED
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6639240 ↗
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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