Bard® X-Force® Nephrostomy Balloon Dilation Catheter 995081Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741080715), received between Sep 10, 2018 and Sep 16, 2026 — classified as 1 injury, 20 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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796647 ↗
• MalfunctionSep 16, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791409 ↗
• MalfunctionJul 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BEFORE USE, THE SHEATH IN GREEN PORTION OF THE BALLOON DILATION CATHETER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458578 ↗
• MalfunctionJul 9, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT BEFORE USE, PHYSICIANS ATTEMPTED SEVERAL TIMES TO BALLOONING THE BALLOON DILATION CATHETER, BUT IT WAS UNSUCCESSFUL. BALLOON DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458426 ↗
• MalfunctionFeb 6, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE BALLOON DILATION CATHETER CONNECTOR TO THE PRESSURE GUN COULD NOT BE LOCKED. AFTER REPLACING IT WITH A NEW SET OF DILATION CATHETERS, IT COULD BE LOCKED AND OPERATED NORMALLY WITH THE SAME PRESSURE GUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650061 ↗
• MalfunctionNov 27, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE NEPHROSTOMY BALLOON DILATION CATHETER RUPTURE OCCURRED DURING INTRAOPERATIVE USE. PER FOLLOW UP ON 11NOV2023, CUSTOMER STATED THAT THE BALLOON RUPTURED 0.5 CM AT THE ANTERIOR END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208695 ↗
• MalfunctionOct 9, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER WAS DAMAGED PRIOR TO USE AND UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894931 ↗
• MalfunctionJul 5, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259682 ↗
• MalfunctionJul 5, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT IN AN ONLINE SURVEY A PHYSICIAN STATED THAT THEY WERE NOT ABLE TO USE THE REFOLDING TOOL TO REFOLD THE BALLOON DILATION CATHETER FOR REINSERTION. THE PHYSICIAN WAS NOT ABLE TO USE THE REFOLDING TOOL TO REFOLD THE 995081- X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 8MM X 15CM, STERILE BECAUSE "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17257767 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN AN ONLINE SURVEY A PHYSICIAN STATED A PERFORATION ADVERSE EVENT, DIRECTLY ATTRIBUTABLE TO THE DEVICE 995081 - X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 8MM X 15CM, STERILE. ALSO STATING THAT THE PATIENT WITH THE DEVICE 996081 - X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 8MM X 15CM, W/ INFLATION DEVICE, STERILE PLACEMENT DID RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION BECAUSE FORCED DILATATION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 14JUN2023, IN AN ONLINE SURVEY, A PHYSICIAN STATED A PERFORATION ADVERSE EVENT, DIRECTLY ATTRIBUTABLE TO THE DEVICE 995081 - X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 8MM X 15CM, STERILE. PHYSICIAN ALSO INDICATED 'PERFORATION' WAS PRESENT PRIOR TO DEVICE PLACEMENT. ALSO STATING THAT THE PATIENT WITH THE DEVICE 996081 - X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 8MM X 15CM, W/ INFLATION DEVICE, STERILE PLACEMENT DID RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION BECAUSE FORCED DILATATION.

  Patient problems: Perforation

  MAUDE report 17199366 ↗
• MalfunctionJun 14, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT IN AN ONLINE SURVEY A PHYSICIAN STATED NO TO THE QUESTION WHEN THEY WERE ASKED IF THEY WERE ABLE TO USE THE REFOLDING TOOL TO REFOLD THE BALLOON DILATION CATHETER FOR REINSERTION. THE PHYSICIAN WAS NOT ABLE TO USE THE REFOLDING TOOL TO REFOLD THE 995081 - X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 8MM X 15CM, STERILE BECAUSE PHYSICIAN STATED THEY WERE NOT SURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17130710 ↗
• MalfunctionMay 23, 2023Nonstandard Device; Nonstandard Device

  CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PHYSICIAN WAS NOT ABLE TO USE THE REFOLDING TOOL TO REFOLD THE BALLOON DILATION CATHETER BECAUSE AFTER FURTHER CASE UPDATE, THE FOLDING BALLOONS WERE NOT SUBJECTIVE FOR THE INNER LINING TRACE CAN REQUIRE ASSERTIONS AND ATTENTIVENESS TO HEAL THE DIGESTIVE TRACT OR URINALYSIS OF PREVENTION FROM PREVIOUS ADVERSE REACTIONS FROM THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16987254 ↗
• MalfunctionJan 17, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT BALLOON OF THE BALLOON DILATION CATHETER WAS FOUND TO BE BROKEN DURING USE. A NEW ONE WAS REPLACED TO COMPLETE THE PROCEDURE. THE PATIENT WAS SAFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183603 ↗
• MalfunctionJun 2, 2022Inflation Problem; Failure to Infuse; Inflation Problem; Failure to Infuse

  IT WAS REPORTED THAT THERE WAS A BALLOON MALFUNCTION IN THE BARD X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 23MAY2022, IT WAS REPORTED THAT THE CATHETER BALLOON FAILED TO INFLATE FULLY. IT WAS STATED THAT THE FAULT OCCURRED DURING USE, BUT NO PATIENT INJURY WAS REPORTED AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER BARD X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575910 ↗
• MalfunctionApr 14, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENTS WERE ASSIGNED TO PERFORM PERCUTANEOUS NEPHROLITHOTOMY. BEFORE USE, THEY WERE ALL CHECKED THAT THE OUTER PACKAGE OF THE PRODUCTS WAS COMPLETE AND THERE WAS NO ABNORMALITY FOUND. AFTER OPENING THE OUTER PACKAGE, IT WAS FOUND THAT THE INTERNAL DISINFECTION PACKAGE WAS NOT SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665849 ↗
• MalfunctionNov 19, 2020Decrease in Pressure; Use of Device Problem; Decrease in Pressure; Use of Device Problem

  IT WAS REPORTED THAT WHILE PERFORMING PERCUTANEOUS NEPHROLITHOTOMY , THE OPERATOR FOUND WATER LEAKING FROM THE TWISTED PART OF THE BALLOON, BODY OF THE CATHETER WHEN THE PRESSURE ROSE TO 15 ATM, WHICH WAS UNUSABLE. PRIOR TO THE USE, THE OUTER PACKAGE OF THE PRODUCT WAS CHECKED FOR INTEGRITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10867943 ↗
• MalfunctionSep 10, 2020Burst Container or Vessel; Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT WHEN A DOCTOR WAS INFLATING THE BALLOON WITH A PUMP, THE BALLOON WAS SPLIT IN THE MIDDLE. REPLACED WITH A NEW BALLOON CATHETER FOR THIS PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10516540 ↗
• MalfunctionApr 8, 2020Material Twisted/Bent

  IT WAS REPORTED THAT THE DILATION CATHETER WAS SUBJECT TO BENDING EASILY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9938630 ↗
• MalfunctionOct 8, 2019Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON RUPTURED PRIOR TO INFLATING TO 20ATM.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9166523 ↗
• MalfunctionSep 26, 2019Unintended Ejection; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE X-FORCE BALLOON LEAKED WHEN IT WAS TESTED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9126161 ↗
• MalfunctionSep 10, 2018Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THE BALLOON RUPTURED.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7861919 ↗