Bard® X-Force® Nephrostomy Balloon Dilation Catheter 996081Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10801741127653), received between May 24, 2018 and Sep 25, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Puncture/Hole

  It was reported that during the procedure prior to use, leakage was detected at the tip of the balloon, preventing it from expanding to the specified pressure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899367 ↗
• MalfunctionJun 11, 2026Material Rupture

  IT WAS REPORTED THAT DURING USE INFLATOR RUPTURED. AFTER DRAWING CONTRAST AGENT INTO THE EAGLE INFLATOR AND CONNECTING IT TO THE X FORCE CATHETER, USER MANUALLY PUSHED THE PLUNGER. WHEN THE PRESSURE GAUGE DISPLAYED 7 TO 8 ATM, THERE WAS A LOUD SOUND OF RUPTURE, AND CONTRAST AGENT SPRAYED OUT FROM THE AREA NEAR, VICINITY OF, THE BLACK PLASTIC DIRECTLY BELOW THE MANOMETER. CONTRAST AGENT SPLASHED ONTO FACE. THE CONTRAST AGENT ONLY GOT ON FACE AND DIDN'T CAUSE SERIOUS HARM. THERE WERE NO HEALTH HAZARDS OR ALLOWANCES FOR THE PRACTITIONERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25480172 ↗
• MalfunctionFeb 4, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A PERCUTANEOUS NEPHROLITHOTOMY WAS PERFORMED. THE PACKAGING OF THE NEPHROSTOMY BALLOON DILATATION CATHETER WAS NOT DAMAGED UPON OPENING. AFTER PLACING THE GUIDEWIRE AND POSITIONING THE BALLOON, SALINE WAS INJECTED BUT THE BALLOON FAILED TO INFLATE AND ESTABLISH A PATHWAY. IT WAS DISCOVERED THAT A TEAR AT THE BALLOON TIP CAUSED LEAKAGE. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE WITHOUT ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264631 ↗
• MalfunctionSep 18, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER INSERTING THE FOLEY CATHETER BALLOON, HEALTH PROFESSIONALS TRIED TO EXPAND IT BUT IT DID NOT INFLATE, CHECKED AND FOUND THAT CONTRAST MEDIUM WAS LEAKING FROM THE CONNECTION BETWEEN THE INFLATION LUMEN AND THE PRESSURIZER. REPLACED THE CATHETER AND COMPLETED THE PROCEDURE WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084161 ↗
• MalfunctionApr 9, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PRESSURE DID NOT REACH THE LEVEL AS IT WAS LOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21806431 ↗
• MalfunctionSep 23, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE ERICS PROCEDURE THE BALLOON DILATION CATHETER FAILED TO INFLATE PROPERLY BECAUSE CONTRAST LIQUID LEAKAGE FROM THE MANOMETER DURING FLUID INSUFFLATION. (BATCH#BMGWAT01, BATCH#BMGYFM44). PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 09SEP2024, CUSTOMER CONFORMED, EVENT DURING USE AND NEED TO CHANGE PERCUTANEOUS DILATATION DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278868 ↗
• MalfunctionAug 8, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT THE SPECIALIST WAS PERFORMED A PCNL PROCEDURE, THAT REQUIRED THE USE OF A BALLOON DILATATION CATHETER, WHILE THE BALLOON WAS INJECTED WITH WATER WITH THE BD PRESSURE PUMP, THE PRESSURE PUMP BURST AND WAS UNABLE TO CONTINUE, AND THE PROCEDURE WAS CONTINUED AFTER REPLACING THE P UMP WITH A NEW ONE, WHICH DELAYED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940113 ↗
• MalfunctionNov 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN THEY OPENED THE STERILE PACK TO USE BALLOON DILATION CATHETER AND SUCKED THE CONTRAST AGENT INTO A SYRINGE WITH A MANOMETER, IT LEAKED FROM THE TOP OF THE SYRINGE. THE BALLOON DILATION CATHETER WAS NOT USED BECAUSE THERE WAS ONLY ONE SET IN STOCK AT THE HOSPITAL. AS PER INFORMATION MENTIONED IN THE INTERNAL BD COMMENTS ON 01NOV2023, STATED THAT THEY COULD NOT CONFIRM ANY ABNORMALITIES SUCH AS CRACKS OR DAMAGE ON THE ENTIRE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159114 ↗
• MalfunctionSep 1, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF THE BALLOON DILATATION CATHETER HAD UNKNOWN DAMAGE AND BECAME UNUSABLE. THE AFFECTED PRODUCT WAS NOT USED ON A PATIENT. STATED THAT THERE WAS A SURGICAL DELAY AND PROLONGED SURGERY. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 25AUG2023, STATED THAT THE EXACT TYPE OF DAMAGE TO BALLOON WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17671902 ↗
• InjuryJul 6, 2023Device Handling Problem; Device Handling 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. AS 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17265985 ↗
• MalfunctionJun 14, 2023Inflation Problem; Inflation Problem

  CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT NO WHEN THEY WERE ASKED IF THEY WERE ABLE TO SUCCESSFULLY DILATE THE NEPHROSTOMY TRACT. THE PHYSICIAN WAS NOT ABLE TO SUCCESSFULLY DILATE THE NEPHROSTOMY TRACT FOR THE DEVICE 996081 - X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 8MM X 15CM, W/ INFLATION DEVICE, STERILE BECAUSE PHYSICIAN STATED NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125490 ↗
• MalfunctionMay 30, 2023Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT IN AN ONLINE SURVEY THE PHYSICIAN STATED NO TO THE QUESTION, WERE YOU 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 996081 - X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 8MM X 15CM, W/ INFLATION DEVICE, STERILE BECAUSE DIFFICULT TO MANEUVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019038 ↗
• InjuryMay 19, 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 TISSUE TRAUMA (HEMATURIA, BLEEDING) ADVERSE EVENT, DIRECTLY ATTRIBUTABLE TO THE DEVICE 996081 - X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 8MM X 15CM, W/ INFLATION DEVICE, STERILE. ALSO STATED THAT THE PATIENT EXPERIENCED UTI PRIOR TO DEVICE 996081 - X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 8MM X 15CM, W/ INFLATION DEVICE, STERILE PLACEMENT AND DIDN'T RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematuria

  MAUDE report 16961139 ↗
• MalfunctionMar 30, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE GAUGE BROKE OFF ON EAGLE INFLATION DEVICE FROM X-FORCE BALLOON KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644552 ↗
• MalfunctionJan 28, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE BALLOON DILATION CATHETER WAS UNPACKED AND CONNECTED TO THE PUMP PROPERLY PRIOR TO OPERATION. AFTER THE SALINE WAS INJECTED, THE BALLOON COULD NOT BE INFLATED PROPERLY AND LEAKED LIQUID. THIS MADE THE PROCEDURE UNABLE TO BE CONDUCTED PROPERLY. THE USER REPLACED WITH A NEW BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261599 ↗
• MalfunctionApr 25, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE THAT THERE WAS NO ISSUE WITH THE PACKAGE, BUT WHEN THE IT WAS OPENED, THE BALLOON DILATION CATHETER WAS FOUND TO BE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192735 ↗
• MalfunctionDec 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN USING THE BALLOON DILATION CATHETER, THE INSUFFLATOR PRESENTED A SUDDEN WATER AND PRESSURE LEAKAGE. THEY STATED THAT IT DID NOT CAUSE HARM TO THE PATIENT, BUT CAUSED DIFFICULTLY IN CARRYING OUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923640 ↗
• MalfunctionOct 9, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON WAS BURST.

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

  MAUDE report 10656446 ↗
• MalfunctionMay 24, 2018Break

  IT WAS REPORTED THAT THE INFLATION DEVICE WAS BROKEN DURING PNL SURGERY. IT WAS LATER REPORTED THAT THE O-RING OF THE INFLATION DEVICE WAS BROKEN DURING USE. THE PROCEDURE WAS NOT DELAYED, ANOTHER DEVICE WAS USED.

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

  MAUDE report 7541330 ↗