Bard® X-Force® Balloon Dilation Catheter 998806Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10801741052771), received between Dec 21, 2017 and Dec 3, 2025 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON DILATION CATHETER BALLOON WAS OPENED AND FOUND TO BE DAMAGED, WITH THE PRESSURE PUMP LEAKING. THEY REPLACED WITH A NEW BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708808 ↗
• MalfunctionDec 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON DILATION CATHETER BALLOON WAS OPENED AND FOUND TO BE DAMAGED, WITH THE PRESSURE PUMP LEAKING. THEY REPLACED WITH A NEW BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708791 ↗
• MalfunctionAug 12, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BEFORE PERFORMING URETERAL STRICTURE DILATION SURGERY, WHEN THE URETERAL STRICTURE BALLOON OF THE BALLOON DILATATION CATHETER WAS OPENED FOR USE, IT WAS CLEARLY SEEN THAT THE PRESSURE PUMP WAS LEAKING WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783190 ↗
• MalfunctionJun 24, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT URETEROSCOPY LITHOTRIPSY FOR KIDNEY STONES. BECAUSE THE PATIENT HAD STENOSIS, THEY PLANNED TO USE BALLOON SET 998806 FOR DILATION. WHEN THE SURGICAL PROCEDURE ENTERED THE BALLOON DILATION STAGE, THE BALLOON WAS IMPLANTED TO DILATE THE URETER. THE BALLOON WAS DILATED WITH AN AIR PUMP, BUT IT WAS FOUND THAT THE BALLOON COULD NOT BE EFFECTIVELY EXPANDED. THE BALLOON WAS TAKEN OUT FOR IN VITRO TESTING, AND IT WAS FOUND THAT THE BALLOON COULD NOT BE OPENED. ACTUAL VIDEOS, SAMPLES AND PHOTOS CAN BE SEEN. THE SPECIFIC ORIGINAL REASON WAS UNKNOWN. THE HOSPITAL ROUTINELY USES BALLOONS AND HAS RICH EXPERIENCE IN USING BALLOONS. AFTER CLINICAL JUDGMENT, A NEW SET OF BALLOONS WAS CHOSEN. THE PRODUCT SUCCESSFULLY COMPLETED THE SUBSEQUENT OPERATIONS WITHOUT ANY PROBLEMS, AND THE OPERATION WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319185 ↗
• MalfunctionMay 6, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BEFORE THE URETERAL STRICTURE DILATION SURGERY, WHEN THE URETERAL STRICTURE BALLOON DILATION CATHETER WAS OPENED AND READY FOR USE, IT WAS OBVIOUS THAT THE PRESSURE PUMP GAUGE WAS BROKEN. THE PRESSURE VALUE DID NOT CHANGE AFTER SLOWLY INCREASING THE PRESSURE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 18APR2025, STATED THAT THE BALLOON HAD BEEN USED ON PATIENTS, BUT AT THAT TIME, DUE TO A LEAK IN THE PUMP, THERE WAS NO SIGNIFICANT IMPACT ON PATIENTS, HEALTH CARE PROFESSIONALS, OR OTHERS. HOWEVER, THERE HAD BEEN SEVERAL CASES OF THIS SITUATION, AND THE HEAD NURSE AND SURGEON IN THE OPERATING ROOM HAD ASKED US TO GIVE AN EXPLANATION OF THE PRODUCT QUALITY. LOT#BMJNFM09 AND LOT#UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968886 ↗
• MalfunctionApr 29, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BEFORE THE URETERAL STRICTURE DILATION SURGERY, WHEN THE URETERAL STRICTURE BALLOON DILATION CATHETER WAS OPENED AND READY FOR USE, IT WAS OBVIOUS THAT THE PRESSURE PUMP GAUGE WAS BROKEN. THE PRESSURE VALUE DID NOT CHANGE AFTER SLOWLY INCREASING THE PRESSURE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 18APR2025, STATED THAT THE BALLOON HAD BEEN USED ON PATIENTS, BUT AT THAT TIME, DUE TO A LEAK IN THE PUMP, THERE WAS NO SIGNIFICANT IMPACT ON PATIENTS, HEALTH CARE PROFESSIONALS, OR OTHERS. HOWEVER, THERE HAD BEEN SEVERAL CASES OF THIS SITUATION, AND THE HEAD NURSE AND SURGEON IN THE OPERATING ROOM HAD ASKED US TO GIVE AN EXPLANATION OF THE PRODUCT QUALITY. LOT#BMJNFM09 AND LOT#UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926076 ↗
• MalfunctionAug 6, 2024Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON DILATATION PUMP LEAKED DURING USE, MAKING IT IMPOSSIBLE FOR THE BALLOON TO BE INFLATED AND EXPANDED. PER FOLLOW UP INFORMATION RECEIVED ON 26JUL2024, STATED THAT THE BALLOON WAS NOT BROKEN. THE PRESSURIZED PUMP LEAKED SO THAT THE BALLOON COULD NOT BE EXPANDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918484 ↗
• InjuryMay 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER OPENED THE PACKAGE OF THE URETERAL BALLOON DILATION CATHETER. AND FOUND THAT IT COULD NOT BE PRESSURIZED AFTER NORMAL USE, AND THEN TOOK OUT THE BALLOON FOR TESTING AND FOUND THAT THE TIP WAS LEAKING. THE USER EXPERIENCED PROLONGED OPERATION TIME AND HAS BEEN EXPOSED TO HARMFUL SUBSTANCES, BLOOD, OR BODILY FLUIDS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 19250386 ↗
• InjuryMay 6, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE OPERATION, THE WATER LEAKED FROM THE INTERFACE BETWEEN THE WATER PUMP AND THE URETERAL BALLOON DILATION CATHETER AND THE PRESSURE DROPPED, AND THE OPERATION COULD NOT BE COMPLETED AFTER REPEATED ADJUSTMENTS. A NEW BALLOON WAS REPLACED, AND THE SURGERY WAS CONTINUED. THE USER EXPERIENCED PROLONGED SURGERY TIME AND THE USER HAS BEEN EXPOSED TO HARMFUL SUBSTANCES, BLOOD, OR BODILY FLUIDS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. AS PER THE FOLLOW UP INFORMATION RECEIVED ON 30APR2024, THE CUSTOMER STATED THAT NO BLEEDING WAS OBSERVED DURING THE SURGERY.

  Patient problems: Exposure to Body Fluids

  MAUDE report 19249992 ↗
• MalfunctionApr 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE CUSTOMER'S SURGERY, IT WAS DISCOVERED THAT THERE WAS WATER LEAKAGE AT THE INTERFACE BETWEEN THE WATER PUMP AND THE BALLOON DILATION CATHETER, AND THE PRESSURE DROPPED. AFTER REPEATED ADJUSTMENTS, THE SURGERY COULD NOT BE COMPLETED. SO, THE NEW BALLOON WAS REPLACED AND THE SURGERY CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018915 ↗
• MalfunctionNov 15, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE SURGERY FOR URETERAL STRICTURE USING A BALLOON DILATION CATHETER, THE DOCTOR FOUND THAT THE PUMP COULD NOT PRESSURIZE THE BALLOON. AFTER REPLACING IT WITH A SET OF U30, THE SURGERY COULD BE NORMAL. AS PER INFORMATION MENTIONED IN THE INTERNAL BD COMMENTS ON 30OCT2023, STATED THAT THE PRODUCT DID NOT SHOW ANY DEFECTS FROM THE OUTSIDE. HX: THE PATIENT HAD SURGERY FOR URETERAL STRICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139752 ↗
• MalfunctionOct 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE STERILE WATER LEAKED FROM THE INFLATION DEVICE OF THE URETERAL BALLOON DILATION CATHETER. THE REPRESENTATIVE COULD NOT CONFIRM THE NUMBER AND CONFIRMED DAMAGE SUCH AS CRACKS AND DEFORMATION THROUGHOUT THE PRODUCT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 27SEP2023, CLARIFIED THAT THE DEVICE WAS USED ON THE PATIENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 04OCT23, THE REPRESENTATIVE CONFIRMED THAT NO DAMAGE, SUCH AS CRACKS OR DEFORMATION, WAS OBSERVED THROUGHOUT THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913913 ↗
• MalfunctionMay 23, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT PRIOR TO USE IN THIS PATIENT WITH URETEROSTENOSIS, THE DOCTOR INSPECTED AND TESTED THE DEVICE AND FOUND THAT THE BALLOON LEAKED WATER. AND A NEW ONE WAS USED AND NO PROBLEM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986384 ↗
• MalfunctionNov 23, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PUMP SUPPLIED WITH THE X-FORCE U30 URETEROSCOPIC BALLOON DILATION CATHETER WAS FOUND TO BE MALFUNCTIONED UPON OPENING OF THE PACKAGE AND THE POINTER DID NOT MOVE WHEN PRESSURIZING. IT WAS MENTIONED THAT THE PATIENT'S CONDITION WAS GOOD AND THE PATIENT HAD INFECTIOUS DISEASE. AS PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 15NOV2022, IT WAS STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852113 ↗
• MalfunctionAug 15, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PHYSICIAN INSPECTED THE BALLOON DILATION CATHETER PRIOR TO OPERATION FOR A PATIENT WITH URETHRAL STENOSIS AND NO PROBLEM WAS NOTED. HOWEVER, THE PRESSURIZATION PUMP LEAKED WATER DURING DILATATION FOR THE PATIENT. THE EVENT INCLUDED EXTRA OPERATION AND DRUG THERAPY. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON (B)(6) 2022, THE EXTRA OPERATION AND DRUG THERAPY THEY HAD WAS THE REPLACEMENT OF NEW DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224680 ↗
• MalfunctionApr 15, 2022Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE USER TRIED TO INFLATE THE BALLOON OF BALLOON DILATION CATHETER AT THE STENOSIS, IT DID NOT INFLATE. WHEN THE PERSON IN CHARGE OF THE AGENCY VISUALLY CHECKED AFTER COLLECTING THE ACTUAL PRODUCT, IT WAS FOUND THAT THERE WAS A HOLE IN THE SHAFT PART IN FRONT OF THE BALLOON. ALTHOUGH, IT WAS STATED THAT THERE WAS A HOLE IN THE SHAFT PART, DOCTORS AND NURSES WHO WERE AT THE SITE AT THE MOMENT HAD COMMENTED ON "POSSIBILITY OF OPERATION IN THE PROCEDURE WHEN INSERTING THE GUIDE WIRE". .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119110 ↗
• MalfunctionNov 11, 2020Device Handling Problem; Material Split, Cut or Torn; Device Handling Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE THE X FORCE U30 URETEROSCOPIC BALLOON DILATION MATCHING PUMP WAS FAILING TO WORK BECAUSE ONE PART OF THE PUMP WAS SLIT.

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

  MAUDE report 10822841 ↗
• MalfunctionMar 11, 2020Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT FLUID LEAKED FROM THE STOPCOCK CONNECTOR. THE EVENT OCCURRED WHILE FLUIDS WERE BEING INJECTED INTO THE BALLOON USING THE EAGLE INFLATION DEVICE DURING URETEROSTENOSIS EXPANSION PROCEDURE. THE STOPCOCK WAS CONFIRMED TO BE FIRMLY IN PLACE.

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

  MAUDE report 9820381 ↗
• MalfunctionDec 3, 2019Partial Blockage; Partial Blockage; Break

  IT WAS REPORTED THAT THERE WAS DAMAGE TO THE BALLOON ON THE X-FORCE DILATION CATHETER FOUND BEFORE USE.

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

  MAUDE report 9401100 ↗
• MalfunctionSep 24, 2019Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE FLUID LEAKED FROM THE CONNECTION BETWEEN THE PRESSURE PUMP AND THE CATHETER, WHILE THE FLUID WAS BEING FILLED INTO THE BALLOON USING THE PRESSURE PUMP DURING THE PROCESS OF URETEROSTENOSIS. IT WAS ENSURED THAT THE PRESSURE PUMP AND THE CATHETER WERE FASTENED SECURELY.

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

  MAUDE report 9109507 ↗
• MalfunctionFeb 6, 2019Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE X-FORCE INFLATION PORT LEAKED DURING INFLATION. THE LEAK POINT WAS ALLEGEDLY AT THE JUNCTION OF THE PORT AND THE PRESSURE PUMP.

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

  MAUDE report 8309998 ↗
• MalfunctionNov 8, 2018Difficult to Open or Close

  IT WAS REPORTED THAT THE STOPCOCK VALVE ON THE THREE-PORT OF THE CATHETER WOULD NOT OPEN.

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

  MAUDE report 8051949 ↗
• MalfunctionDec 21, 2017Deflation Problem; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE BALLOON COULD NOT BE DEFLATED COMPLETELY. THE USER ATTEMPTED TO MANIPULATE THE BALLOON TWICE, BUT FAILED BOTH TIMES.

  Patient problems: No Information

  MAUDE report 7138073 ↗