Bard® X-Force® Balloon Dilation Catheter 998706Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10801741052740), received between Mar 19, 2018 and Aug 26, 2026 — classified as 4 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (15 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452739 ↗
• MalfunctionAug 26, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452738 ↗
• 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 23708792 ↗
• 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 23708519 ↗
• InjuryMar 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A URETEROSCOPIC BALLOON DILATATION SURGERY. AFTER THE BALLOON DILATION CATHETER WAS PLACED AT THE TARGETED POSITION, OBSERVATION UNDER THE MICROSCOPE SHOWED THAT THE BALLOON COULD NOT REMAIN INFLATED. WHEN THE BALLOON WAS OBSERVED EXTERNALLY, IT WAS FOUND THAT THE BALLOON BODY WAS LEAKING. THE BALLOON WAS REPLACED WITH A NEW ONE, AND THE SURGERY WENT SMOOTHLY. PATIENT WAS EXPOSED TO HAZARDOUS MATERIALS, BLOOD OR BODY FLUIDS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 21559544 ↗
• MalfunctionFeb 12, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON OF THE BALLOON DILATION CATHETER LEAKED WHEN IT WAS FILLED WITH WATER AND COULD NOT BE PRESSURIZED SMOOTHLY. THE SOLUTION WAS TO REPLACE THE BALLOON WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363677 ↗
• MalfunctionDec 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN URETEROSCOPIC LITHOTRIPSY AND LITHOTRIPSY PROCEDURE ON (B)(6) 2024, THE SURGEON DISCOVERED A LEAK AT THE CONNECTION BETWEEN THE PRESSURE PUMP AND THE BALLOON DILATION CATHETER DURING THE TESTING PROCESS. AFTER OPENING THE PACKAGE, THEY WERE UNABLE TO ACHIEVE THE PREDETERMINED PRESSURE VALUE, SO THEY REPLACED THE BALLOON PRODUCT WITH A NEW ONE FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20986338 ↗
• MalfunctionDec 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A URETERAL STRICTURE WAS ENCOUNTERED DURING URETERAL STONE SURGERY USING A URETEROSCOPIC BALLOON, AND A PRESSURIZED PUMP WAS FOUND TO BE LEAKING DURING USE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SET OF BALLOONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825093 ↗
• MalfunctionNov 21, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUSTOMER USED THE PRODUCT URETEROSCOPIC BALLOON DILATATION CATHETER, WHICH DID NOT WORK PROPERLY WHEN PRESSURIZED WITH A PRESSURE PUMP. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 12NOV2024, STATED THAT THE BALLOON WAS NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745879 ↗
• MalfunctionJul 19, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT OPENED THE PACKAGE, THE PATIENT HAD LEFT URETERAL STENOSIS, THE BALLOON LEAKED AFTER WATER WAS GIVEN, AND COULD NOT BE USED. THEY OPENED A NEW BALLOON. THE BAD BALLOON COULD NOT BE CHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781812 ↗
• MalfunctionJun 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON MAY 15, 2024, WHEN THE (B)(6) PERFORMED A URETERAL DILATION OPERATION, A URETERAL BALLOON DILATION CATHETER WAS REQUIRED DURING THE OPERATION. AFTER OPENING THE OUTER PACKAGING OF THE PRODUCT, WHEN THE SYRINGE WAS FILLED WITH WATER, IT WAS FOUND THAT THE CONNECTOR LEAKED AND COULD NOT BE USED. SUBSEQUENTLY, THE SURGERY WAS CONTINUED WITH NEW PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458204 ↗
• MalfunctionMay 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE URETERAL DILATATION SURGERY WAS PERFORMED ON (B)(6) 2024, THE URETERAL BALLOON DILATATION CATHETER WAS REQUIRED TO BE USED DURING THE SURGERY, AND AFTER OPENING THE OUTER PACKAGING OF THE PRODUCT, THE CONNECTOR WAS FOUND TO BE LEAKING WHEN THE SYRINGE WAS BEING FILLED WITH WATER, AND IT COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308984 ↗
• MalfunctionDec 13, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ON NOVEMBER 23, THE PATIENT UNDERWENT URETERAL STENOSIS BALLOON DILATION CATHETER, OPENED THE BALLOON AND SUCCESSFULLY USED THE IMPLANTATION TO START PRESSURIZING TO 20 ATMOSPHERES, AND THEN THE PUMP WAS BROKEN, AND THE REPLACEMENT OF OTHER PRODUCTS WAS DIRECTLY USED FOR DILATION, WHICH DID NOT AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18322713 ↗
• MalfunctionNov 14, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE WHEN THEY OPENED THE PACKAGE OF URETERAL BALLOON DILATION CATHETER AND PRESSED, THEY FOUND THAT THE BALLOON PRESSURE PUMP WAS BROKEN AND COULD NOT BE USED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130492 ↗
• InjurySep 20, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING THE OPERATION, THE BALLOON OF THE URETERAL BALLOON DILATION CATHETER WAS DAMAGED WHILE PERFORMING DILATATION. IT WAS THEN REMOVED AND HAD NO ADVERSE IMPACT ON THE PATIENT. THE USER WAS EXPOSED TO HAZARDOUS, BLOOD, OR BODILY FLUIDS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 17780092 ↗
• MalfunctionAug 28, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT WITH CALCULI UNDERWENT URETER BALLOON DILATION ON (B)(6). UPON OPENING THE PACKAGE, THE PRODUCT WAS FOUND TO HAVE RUPTURED, AND THERE WERE HOLES IN THE TUBING. THE PRODUCT WAS NOT USED AND WAS REPLACED WITH ANOTHER PRODUCT FOR DILATATION. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630678 ↗
• MalfunctionAug 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT WITH CALCULI UNDERWENT URETER BALLOON DILATION ON (B)(6). UPON OPENING THE PACKAGE, THE PRODUCT WAS FOUND TO HAVE RUPTURED, AND THERE WERE HOLES IN THE TUBING. THE PRODUCT WAS NOT USED AND WAS REPLACED WITH ANOTHER PRODUCT FOR DILATATION. THERE WAS NO IMPACT ON THE PATIENT. AS PER THE FOLLOW UP INFORMATION RECEIVED ON 25AUG2023, THE SHAFT REGION WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595306 ↗
• InjuryAug 11, 2022Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood 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 BALLOON 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, STATED THAT THERE WAS NO DAMAGE ON PATIENT. THEY JUST REPLACED A NEW DEVICE.

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

  MAUDE report 15211283 ↗
• MalfunctionJul 12, 2022Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING INSPECTION OF THE BALLOON DILATION CATHETER PRIOR TO OPERATION, THE DOCTOR FOUND THAT THE BALLOON LEAKED WATER WHEN BEING INFLATED USING A PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988437 ↗
• InjuryApr 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEAK OF CONTRAST OCCURRED AT THE BALLOON DILATION CATHETER DURING THE PROCESS OF INFLATION AND THEN REPLACED WITH A NEW DEVICE. IT WAS MENTIONED THAT AN EXTRA OPERATION OR DRUG THERAPY WAS INCLUDED FOR THIS INCIDENT. AS PER THE FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2022, THERE WAS NO SAMPLE AVAILABLE AND A NEW CATHETER WAS REPLACED.

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

  MAUDE report 14189473 ↗
• MalfunctionApr 19, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRESSURE PUMP WAS BROKEN AND FUNCTIONED IMPROPERLY, SO WATER LEAKS OCCURRED IN THE URETERAL BALLOON CATHETER DURING INFLATION. PER FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2022, THE LEAK OCCURRED ON THE PRESSURE PUMP AT THE CONNECTION OF PRESSURE PUMP AND CATHETER. THERE WAS NO ISSUE WITH THE BALLOON DILATION CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142473 ↗
• MalfunctionApr 18, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRESSURE PUMP WAS BROKEN AND FUNCTIONED IMPROPERLY, SO WATER LEAKAGE OCCURRED IN THE URETERAL BALLOON CATHETER DURING INFLATION. IT WAS ALSO STATED THEN A NEW BALLOON KIT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135071 ↗
• MalfunctionJan 31, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER BALLOON BURST DURING INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392477 ↗
• MalfunctionSep 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE URETERAL CATHETER BALLOON HAD WATER LEAKED DURING INFLATION WHILE PERFORMING URETEROSTENOSIS OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439095 ↗
• MalfunctionJan 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT EXPANSION OF URETEROSTENOSIS WAS PERFORMED FOR THE PATIENT. INTRAOPERATIVELY, THE CATHETER BALLOON WAS INJECTED WITH WATER TO TEST INFLATION. THE BALLOON BODY LEAKED WATER AT 15 ATM AND BECAME UNUSABLE. THE OUTER PACKAGE OF THE PRODUCT WAS CHECKED PRIOR TO USE AND NO ABNORMALITIES WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11207304 ↗