Bard® X-Force® Balloon Dilation Catheter 998810Recalls & reported problems
C. R. Bard, Inc. · Bard® X-Force® Balloon Dilation Catheter · Class 2
All models of Bard X-Force Balloon Dilation Catheter (22)
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 10801741052788), received between Jul 26, 2022 and Dec 15, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (2 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
Device problems
- Component Misassembled2
- Failure to Infuse1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2022Failure to Infuse; Component Misassembled; Failure to Infuse; Component Misassembled
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON PRESSURE DID NOT RISE DUE TO A DEFECTIVE SYRINGE. IT WAS STATED THAT ONLY THE SYRINGE WAS RECOVERED. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 09DEC2022, STATED THAT THE SYRINGE IN THE DESCRIPTION MEANS THE INFLATION DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15986385 ↗MalfunctionJul 26, 2022Material Fragmentation; Component Misassembled; Material Fragmentation; Component Misassembled
IT WAS REPORTED THAT THE SYRINGE WAS BROKEN AND IT WAS DIFFICULT TO INFLATE THE BALLOON OF URETERAL DILATION BALLOON CATHETER ON THE DAY OF USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15102626 ↗
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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