Bard® X-Force® Balloon Dilation Catheter 998006Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10801741052801), received between Jun 13, 2017 and Sep 15, 2026 — classified as 3 injuries, 22 malfunctions.

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

• MalfunctionSep 15, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781988 ↗
• InjuryDec 31, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT ON (B)(6) 2024, WHEN THEY PERFORMED A URETERAL STENOSIS DILATATION OPERATION, THEY CONNECTED THE BALLOON DILATION CATHETER AND THE PRESSURE PUMP, PLACED THE BALLOON CATHETER ALONG THE GUIDE WIRE, AND SIMULTANEOUSLY PUSHED THE BALLOON DILATION CATHETER INTO THE URETER UNDER DIRECT VISION OF THE URETEROSCOPE. AFTER PASSING THROUGH THE STRICTURE SECTION, THEY PUSHED THE PRESSURE PUMP AND FOUND THAT THE PRESSURE COULD NOT BE INCREASED. AT THE SAME TIME, THEY FOUND THAT THERE WAS A LEAK AT THE CONNECTION BETWEEN THE BALLOON AND THE PRESSURE PUMP, SO THEY IMMEDIATELY REPLACED THE NEW BALLOON PRODUCT AND CONTINUED TO COMPLETE THE OPERATION. THERE WAS A DELAY IN SURGERY. AND THE PATIENT WAS EXPOSED TO BLOOD OR BODY FLUIDS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 21047026 ↗
• MalfunctionAug 28, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT NO PRESSURE WAS APPLIED FROM THE BEGINNING DUE TO FAULTY CONNECTION BETWEEN METER AND SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633781 ↗
• MalfunctionJul 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DOCTOR FOUND THAT THE BALLOON OF THE CATHETER LEAKED WATER UPON OPENING THE PACKAGE AND DID NOT USE IT ON THE PATIENT. IT WAS STATED THAT THE KIT WAS REPLACED WITH A NEW KIT OF THE X-FORCE U30 URETEROSCOPIC BALLOON DILATION CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17364136 ↗
• MalfunctionMay 12, 2023Accessory Incompatible; Difficult to Insert; Accessory Incompatible; Difficult to Insert

  IT WAS REPORTED THAT THE GUIDE WIRE COULD NOT BE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918893 ↗
• MalfunctionApr 18, 2023Material Fragmentation; Component Misassembled; Material Fragmentation; Component Misassembled

  IT WAS REPORTED THAT WHEN PRESSURE WAS APPLIED WITH AN INFLATION DEVICE, AN EXPLOSION-LIKE SOUND WAS HEARD, THE METER PART FLEW TO THE ASSISTANT NURSE'S EYES. PATIENT STATED THAT WHEN HE CHECKED THE FLYING OBJECT, IT WAS THE METER PART, AND THE MANOMETER PART WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763750 ↗
• InjuryDec 20, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT UNDERWENT URETHRAL STRICTURE BALLOON DILATATION ON (B)(6) 2022. DURING THE OPERATION, A BALLOON WAS INSERTED, AND THE BALLOON WAS DILATED AFTER FILLING WITH WATER. AFTER DRAWING THE WATER OUT, THE URETEROSCOPIC BALLOON DILATION CATHETER COULD NOT BE PULLED OUT FROM THE URETHRA. AFTER THE BALLOON WAS FINALLY PULLED OUT, A BREAK WAS FOUND IN THE BALLOON. URETHROSCOPY WAS PERFORMED IMMEDIATELY AND IT WAS FOUND THAT THE PATIENT¿S URETHRA WAS NOT DILATED AND THERE WAS STILL SCAR STENOSIS. THEN, URETHRAL STRICTURE SCAR RESECTION WAS PERFORMED.

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

  MAUDE report 16014814 ↗
• MalfunctionDec 19, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT UNDERWENT URETHRAL STRICTURE BALLOON DILATATION ON (B)(6) 2022. DURING THE OPERATION, A BALLOON WAS INSERTED, AND THE BALLOON WAS DILATED AFTER FILLING WITH WATER. AFTER DRAWING THE WATER OUT, THE URETEROSCOPIC BALLOON DILATION CATHETER COULD NOT BE PULLED OUT FROM THE URETHRA. AFTER THE BALLOON WAS FINALLY PULLED OUT, A BREAK WAS FOUND IN THE BALLOON. URETHROSCOPY WAS PERFORMED IMMEDIATELY AND IT WAS FOUND THAT THE PATIENT¿S URETHRA WAS NOT DILATED AND THERE WAS STILL SCAR STENOSIS. THEN, URETHRAL STRICTURE SCAR RESECTION WAS PERFORMED. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004304 ↗
• MalfunctionAug 10, 2022Burst Container or Vessel; Burst Container or Vessel

  ET 12/6IT WAS REPORTED THAT AFTER THE BALLOON ENTERED THE X-FORCE U30 URETEROSCOPIC BALLOON DILATION CATHETER, DILATATION WAS CONDUCTED AND THE BALLOON WAS BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199963 ↗
• MalfunctionMay 10, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE BALLOON DILATION CATHETER CAP FOR BALLOON PROTECTION COULD NOT BE REMOVED, DURING THE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14348199 ↗
• MalfunctionMay 4, 2022Fluid/Blood Leak; Component Misassembled; Fluid/Blood Leak; Component Misassembled

  IT WAS REPORTED THAT WHEN EXPANDING THE BALLOON WITH AN INFLATION DEVICE, THE PRESSURE COULD NOT BE MAINTAINED AT ALL AFTER RAISING IT TO THE REQUIRED PRESSURE AND LOCKING IT. IT WAS CAUSED DUE TO THE CONTRAST MEDIUM LEAKING FROM THE FLANGER PART OF THE INFLATION DEVICE, AND EVEN IF THE PRESSURIZATION WAS CONTINUED AFTER THAT, IT IDLED AND NO PRESSURE WAS APPLIED. DUE TO THE LEAKAGE OF THE CONTRAST MEDIUM IN THE INFLATION DEVICE, IT WAS REFILLED AND PRESSURIZED, AND THE THREE-WAY STOPCOCK WAS LOCKED TO MAINTAIN THE PRESSURIZATION, AND THERE WAS NO PROBLEM WITH THE CASE ITSELF. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 21APR2022, STATED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14281051 ↗
• MalfunctionNov 10, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE USER WAS UNABLE TO PRESSURIZE THE BALLOON DILATION CATHETER AND IT WAS SUBSTITUTED BY ANOTHER CATHETER. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 29OCT2021, IT WAS UNKNOWN WHETHER THERE WAS ANY DAMAGE IN THE BALLOON AND THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787609 ↗
• MalfunctionOct 18, 2021Difficult to Open or Remove Packaging Material; Physical Resistance/Sticking; Difficult to Open or Remove Packaging Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN THE USER TRIED TO REMOVE THE BALLOON OF THE DILATION CATHETER FROM THE SHEATH PROTECTING IT BEFORE USE, THE SHEATH AND BALLOON WERE STUCK TOGETHER. STATED THAT WHEN THE USER PULLED TOO HARD, THE SHAFT BROKE OFF. THE USER ALSO CONFIRMED THAT THE PROTECTIVE SHEATH HAD NOT BEEN COLLECTED THIS TIME. AS PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 01OCT2021, IT WAS CONFIRMED THAT THE SHEATH AND BALLOON WERE STICKING TOGETHER. WHEN THE USER PULLED THE BALLOON OUT OF THE SHEATH, THE SHAFT BROKE OFF. ALSO CONFIRMED THAT ONLY ONE SAMPLE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647539 ↗
• MalfunctionJan 8, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON RUPTURED ON THE DAY OF USE. PER FOLLOW UP WITH IBC VIA MAIL ON 05JAN2021, IT WAS UNKNOWN IF THERE ARE ANY MISSING PIECES TO THE CATHETER.

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

  MAUDE report 11140620 ↗
• MalfunctionJan 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WATER LEAKED FROM THE CATHETER AND THE BALLOON WAS UNABLE TO INFLATE.

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

  MAUDE report 11127680 ↗
• MalfunctionJul 10, 2019Inflation Problem; Inflation Problem; Pressure Problem

  IT WAS REPORTED THAT THE USER TRIED TO RAISE THE PRESSURE AFTER INFLATING THE BALLOON BUT IT DID NOT RISE MORE THAN A CERTAIN LEVEL.

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

  MAUDE report 8776570 ↗
• MalfunctionFeb 15, 2019Misassembled; Component Missing; Misassembled

  IT WAS REPORTED THAT THERE WAS NO PUMP.

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

  MAUDE report 8343615 ↗
• MalfunctionFeb 14, 2019Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT THE LOWER END OF THE BALLOON RUPTURED AT LESS THAN 20 ATMOSPHERES WHEN THE DOCTOR INJECTED THE CONTRAST AGENT INTO THE BALLOON.

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

  MAUDE report 8339752 ↗
• MalfunctionNov 6, 2018Leak/Splash

  IT WAS REPORTED THAT DURING THE INJECTION OF THE CONTRAST AGENT INTO THE BALLOON BY THE PUMP; IT WAS FOUND THAT THE THREE-PORT AND THE PRESSURE PUMP CONNECTION PORT BEGAN TO LEAK.

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

  MAUDE report 8042858 ↗
• MalfunctionSep 27, 2018Deflation Problem; Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT IT WAS DIFFICULT TO DEFLATE THE CATHETER BALLOON. THE DOCTOR REMOVED THE CATHETER SLOWLY WITH THE BALLOON REMAINING INFLATED. NO PATIENT INJURY REPORTED.

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

  MAUDE report 7913913 ↗
• MalfunctionJul 11, 2018Deflation Problem; Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE BALLOON COULD NOT BE DEFLATED. PER ADDITIONAL INFORMATION RECEIVED FROM THE IBC ON 06/25/2018, THE USER WAS UNABLE TO COMPLETELY DEFLATE THE BALLOON.

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

  MAUDE report 7679523 ↗
• InjuryNov 28, 2017Break; Misassembled; Device Markings/Labelling Problem; Positioning Problem; Misassembled

  IT WAS REPORTED THAT 'OPEN PACKAGE BALLOON MARKER" WAS NOT IN THE CORRECT POSITION. THE POSITION OF THE MARKER WAS SHORTER THAN THE PREVIOUS ONE, CAUSING THE DOCTOR TO POSITION DOWN. THE URETER AND THE BLADDER CONNECTION WERE BROKEN, AND THE PATIENT WAS FOUND TO HAVE PERITONITIS, AND THE PATIENT WAS VOMITING. THE DOCTOR USED DOLANTIN TO STOP THE PAIN.

  Patient problems: Injury; Pain; Peritonitis; Unspecified Infection; Vomiting

  MAUDE report 7063439 ↗
• MalfunctionNov 26, 2017Misassembled; Positioning Problem; Misassembled

  IT WAS REPORTED THAT "OPEN PACKAGE BALLOON" MARKER WAS IN THE WRONG POSITION. THE POSITION OF THE MARKER WAS SHORTER THAN THE PREVIOUS ONE.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 7058341 ↗
• MalfunctionSep 12, 2017Break

  IT WAS REPORTED THAT THE USER WAS UNABLE TO CONNECT THE INFLATION DEVICE TO THE EXTENSION TUBE DUE TO A BREAK. THERE WAS NO MORE INFORMATION FROM THE FACILITY.

  Patient problems: No Information

  MAUDE report 6857820 ↗
• MalfunctionJun 13, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS FOUND AT THE INFLATION SITE OF THE DEVICE DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6639246 ↗