Bard® Renal Sheath 994101Recalls & reported problems
C. R. Bard, Inc. · Bard® Renal Sheath · Class U
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 00801741095061), received between Jun 14, 2023 and Jul 5, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (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
- Inflation Problem1
- Nonstandard Device1
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.
MalfunctionJul 5, 2023Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT A CRITICAL CARE NURSES STATED NO TO THE QUESTION DID THE X-FORCE RENAL SHEATH¿S RADIOPAQUE MARKER PROVIDE ADEQUATE VISIBILITY. THE PHYSICIAN STATED THAT THE RADIOPAQUE MARKER DIDN'T PROVIDE ADEQUATE VISIBILITY FOR THE DEVICE 992101 - X-FORCE® 10MM X 17CM RENAL SHEATH, CLEAR, STERILE BECAUSE NONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17257243 ↗MalfunctionJun 14, 2023Inflation Problem; Inflation Problem
CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT NO TO THE QUESTION WHEN THEY WERE ASKED IF THEY WERE ABLE TO SUCCESSFULLY PLACE THE WORKING SHEATH. THE PHYSICIAN WAS NOT ABLE TO SUCCESSFULLY DILATE THE NEPHROSTOMY TRACT FOR THE DEVICE 994101 - X-FORCE® 10MM X 17CM RENAL SHEATH, STERILE BECAUSE PHYSICIAN STATED NONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17125492 ↗
Other CATHETER, NEPHROSTOMY devices
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- 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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