Bard® X-Force® Balloon Dilation Catheter 998604Recalls & 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
- 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 10801741052702), received between Dec 21, 2017 and Nov 9, 2023 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Burst Container or Vessel1
- Component Missing1
- Failure to Infuse1
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Perforation1
- Tissue Damage1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE URETERAL BALLOON CATHETER CAME AS A 2 PIECE KIT. WHEN THEY RECEIVED THIS, THE BALLOON CATHETER WAS MISSING FROM THE PACKAGE AND THEY ONLY RECEIVED THE INSUFFLATOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18100190 ↗MalfunctionSep 26, 2022Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT WATER COULD NOT BE INJECTED INTO THE FOLEY CATHETER BALLOON AND INFLATION FAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15484692 ↗InjuryMay 10, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility
IT WAS REPORTED THAT AFTER INFLATING AND DEFLATING THE CATHETER, THE PATIENT ALLEGEDLY EXPERIENCED A LONGITUDINAL TEAR OF ABOUT ONE CENTIMETER IN THE BACK SECTION OF THE URETER. THEY INFORMED THE MINISTRY OF HEALTH. THE EXTENT OF THE INTERVENTION IS UNKNOWN.
Patient problems: Perforation; Tissue Damage
MAUDE report 8598774 ↗MalfunctionDec 21, 2017Break; Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE SHAFT WAS DAMAGED AS THE DILATING PRESSURE WAS APPLIED. THE USER STATED THAT THE PRESSURE WAS WITHIN THE DEFINED VALUE AND NO PRESSURED WAS FELT WHILE USING THE DEVICE. THERE WAS NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7138357 ↗
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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