Bard® X-Force® Nephrostomy Balloon Dilation Catheter 995101Recalls & reported problems
C. R. Bard, Inc. · Bard® X-Force® Nephrostomy Balloon Dilation Catheter · Class U
All models of Bard X-Force Nephrostomy Balloon Dilation Catheter (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741080722), received between Jul 10, 2017 and Dec 15, 2023 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 Vessel6
- Fluid/Blood Leak1
- Inadequate Instructions for Healthcare Professional1
- Material Deformation1
- Material Fragmentation1
- Out-Of-Box Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- No Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2023Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DILATION CATHETER BALLOON RUPTURED WAS FOUND DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18335061 ↗MalfunctionNov 20, 2023Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE 10MM NEPHROSTOMY BALLOON OF THE BALLOON DILATION CATHETER HAD RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18169120 ↗MalfunctionJan 3, 2023Burst Container or Vessel; Material Fragmentation; Burst Container or Vessel; Material Fragmentation
IT WAS REPORTED THAT THE BALLOON WIRE OF THE BALLOON DILATION CATHETER WAS BROKEN. THE DEVICE WAS NOT USED ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16090168 ↗MalfunctionDec 30, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE BALLOON IN THE DILATION CATHETER WAS LEAKING THE FLUID AND WOULD NOT FULLY INFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13120948 ↗MalfunctionNov 7, 2021Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional
IT WAS REPORTED THAT THE WRONG INTENDED FOR USE (IFU) WAS ATTACHED IN THE BALLOON DILATION CATHETER PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12760431 ↗MalfunctionMar 12, 2020Burst Container or Vessel
IT WAS REPORTED THAT THE X-FORCE DILATION CATHETER BALLOON BURST DURING USE. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL 20FEB2020; THERE WERE NO MISSING PIECES TO THE BURST BALLOON.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9823226 ↗MalfunctionMar 5, 2020Burst Container or Vessel
IT WAS REPORTED THAT THE X-FORCE DILATION CATHETER BALLOON BURST DURING USE. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL 20FEB2020, THERE WERE NO MISSING PIECES TO THE BURST BALLOON.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9792574 ↗MalfunctionOct 18, 2017Out-Of-Box Failure; Material Deformation
IT WAS REPORTED THAT THE SHEATH WAS DEFORMED UPON OPENING THE PACKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6957879 ↗MalfunctionJul 10, 2017Burst Container or Vessel
Other CATHETER, NEPHROSTOMY devices
- Cook G09501Cook Incorporated · CATHETER, NEPHROSTOMY280 reports
- Dawson Mueller G09705Cook Incorporated · CATHETER, NEPHROSTOMY2 deaths215 reports
- Cook G09497Cook Incorporated · CATHETER, NEPHROSTOMY129 reports
- Dawson Mueller G11020Cook Incorporated · CATHETER, NEPHROSTOMY100 reports
- Cook G09502Cook Incorporated · CATHETER, NEPHROSTOMY86 reports
- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall11 reports
- Dawson Mueller G13768Cook Incorporated · CATHETER, NEPHROSTOMY59 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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