Bard® X-Force® Balloon Dilation Catheter 998504Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10801741052672), received between May 1, 2017 and Oct 24, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING SURGERY, CONTRAST MEDIUM LEAKED FROM THE BALLOON DILATION CATHETER BALLOON DURING THE THIRD BALLOON DILATION. PER ADDITIONAL INFORMATION RECEIVED VIA TASK ON 30OCT2025, STATED THAT CONTRAST AGENT LEAKED FROM THE BALLOON PART DURING THE THIRD BALLOON DILATION. THE CONTRAST AGENT LEAKAGE COULD NOT BE CONFIRMED UNTIL THE SECOND DILATION, THE CONTRAST AGENT LEAKED OUT FOR THE THIRD TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23382269 ↗
• MalfunctionJun 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN OPENED THE PRODUCT THE CUSTOMER FOUND THAT THE MANOMETER ON THE EAGLE INFLATION DEVICE WAS DAMAGED IN THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604478 ↗
• MalfunctionDec 7, 2022Inflation Problem; Component Misassembled; Inflation Problem; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS UNABLE TO INFLATE DURING PROCEDURE, NOTICED THAT GAUGE IS STUCK AT 4 TRIED TO INJECT MORE CONTRAST, HOWEVER THE METER AREA DETACHED FROM THE INDEFLATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932349 ↗
• MalfunctionOct 19, 2022Material Fragmentation; Device Handling Problem; Material Fragmentation; Device Handling Problem

  IT WAS REPORTED THAT THE PRESSURE WAS UNABLE TO APPLIED TO THE URETERAL DILATION BALLOON CATHETER EVEN WHEN PRESSURIZED AND THE BALLOON COULD NOT DILATED. AS PER SAMPLE EVALUATION RESULTS RECEIVED ON 27SEP2022, IT WAS REPORTED THAT DURING EVALUATION THE O-RING WAS FOUND TO HAVE DISLOCATED FROM THE ASSEMBLED POSITION AND THE GAUGE NEEDLE WAS OUT OF TOLERANCE DUE TO OVER-PRESSURIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15631863 ↗
• MalfunctionOct 18, 2022Material Fragmentation; Device Handling Problem; Material Fragmentation; Device Handling Problem

  IT WAS REPORTED THAT THE PRESSURE IN THE URETERAL DILATION BALLOON CATHETER DID NOT RAISE EVEN WHEN THE PRESSURE WAS APPLIED BY INFLATION. IT WAS STATED THAT THERE WAS NO PROBLEM WHEN THE SEPARATE INVENTORY WAS OPENED AND USED. AS PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 14JUL2022, IT WAS STATED THAT THE CUSTOMER DID NOT PROVIDE ANY INFORMATION WHETHER THERE WERE ANY HOLES OR TEARS IN THE FOLEY CATHETER BALLOON. AS PER NOTIFICATION RECEIVED FROM INVESTIGATOR ON 30SEP2022, IT WAS STATED THAT DURING EVALUATION IT WAS FOUND THAT THE GAUGE NEEDLE WAS OUT OF THE ZERO POSITION AND THE GAUGE WAS FOUND TO BE BROKEN AT THE GLUE PLUG AREA DUE TO SHOCK DAMAGE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625778 ↗
• MalfunctionJul 22, 2022Inflation Problem; Component Misassembled; Inflation Problem; Component Misassembled

  IT WAS REPORTED THAT THE PRESSURE WAS UNABLE TO BE APPLIED TO THE URETERAL DILATION BALLOON CATHETER EVEN WHEN PRESSURIZED THE BALLOON COULD NOT BE DILATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085871 ↗
• MalfunctionJul 12, 2022Fluid/Blood Leak; Component Misassembled; Fluid/Blood Leak; Component Misassembled

  IT WAS REPORTED THAT CONTRAST AGENT LEAKED FROM THE PLUNGER. THE BARD X-FORCE URETERAL BALLOON CATHETER COULD NOT BE INSERTED DUE TO URETERAL STENOSIS, AND THE URETERAL STENOSIS WAS DILATED WITH A VASODILATOR BALLOON. DURING THE PROCEDURE, THE INFLATION DEVICE ATTACHED TO THE BARD X-FORCE URETERAL BALLOON CATHETER WAS CONNECTED TO THE VASODILATOR BALLOON. WHEN THE PRESSURE WAS RAISED TO 12 ATM, THE PRESSURE DROPPED, AND THE DILUTED CONTRAST MEDIUM LEAKED FROM THE PLUNGER. THE INFLATION DEVICE WAS USED IN A WAY THAT WAS NOT THE ORIGINAL COMBINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14989122 ↗
• MalfunctionJul 11, 2022Inflation Problem; Component Misassembled; Inflation Problem; Component Misassembled

  IT WAS REPORTED THAT THE PRESSURE IN THE URETERAL DILATION BALLOON CATHETER DID NOT RAISE EVEN WHEN THE PRESSURE WAS APPLIED BY INFLATION. IT WAS STATED THAT THERE WAS NO PROBLEM WHEN THE SEPARATE INVENTORY WAS OPENED AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982445 ↗
• MalfunctionMay 16, 2022Burst Container or Vessel; Component Misassembled; Burst Container or Vessel; Component Misassembled

  IT WAS REPORTED THAT THE DILATION CATHETER WAS UNABLE TO MAINTAIN PRESSURE, THE BALLOON WAS NOT DAMAGED AND THE USER ASSUMED THAT IT WAS A MALFUNCTION OF THE INFLATION DEVICE OF THE CATHETER. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 09-MAY-2022, IT LOOKS THAT THERE WAS BALLOON RUPTURE FROM THE PHOTOS.

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

  MAUDE report 14407663 ↗
• MalfunctionMar 17, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AFTER THE PLACEMENT, A CONTRAST MEDIUM WAS INJECTED TO INFLATE THE BALLOON, BUT THE BALLOON DID NOT INFLATE. WHEN THE URETERAL DILATION BALLOON CATHETER WAS REMOVED FROM THE BODY AND VISUALLY EXAMINED, WATER LEAKAGE WAS OBSERVED DUE TO THE BALLOON RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13791585 ↗
• MalfunctionDec 6, 2020Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT THE EAGLE INFLATION DEVICE WAS DAMAGED AND STERILIZED WATER WAS LEAKED, WHEN USED FOR URETERAL DILATION IN THE OPERATING ROOM.

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

  MAUDE report 10955796 ↗
• MalfunctionApr 2, 2020Material Rupture; Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT UPON INFLATING THE BALLOON OF THE CATHETER, A RUPTURE ON THE SHEATH WAS NOTED (1 CM FROM THE BALLOON). THE CATHETER WAS REMOVED AND ANOTHER CATHETER WAS USED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 12 MARCH 2020 FROM IBC REPRESENTATIVE, "THE SURGEON BEGAN TO INFLATE THE BALLOON, WHICH RESPONDED WELL, THEN THEY HEARD A SMALL NOISE AND FOUND THAT THE SHEATH WAS RUPTURED." PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 12 MARCH 2020 FROM IBC REPRESENTATIVE, THE SHEATH THAT THE COMPLAINANT WAS REFERRING TO WAS THE CATHETER. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17 MAR 20 FROM IBC REPRESENTATIVE, THERE WERE NO MISSING PIECES OF THE BALLOON.

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

  MAUDE report 9916487 ↗
• MalfunctionApr 17, 2019Break; Burst Container or Vessel; Leak/Splash; Burst Container or Vessel

  IT WAS REPORTED THAT THE SHAFT ON THE CATHETER WAS BROKEN, THEREFORE THE CATHETER WAS REMOVED. THE BREAK WAS FOUND AS THE CONTRAST LEAKED AS THE PRESSURE ROSE.

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

  MAUDE report 8525195 ↗
• MalfunctionNov 30, 2018Burst Container or Vessel; Break; Burst Container or Vessel

  IT WAS REPORTED THAT THE SHAFT OF THE X-FORCE DILATION CATHETER WAS DAMAGED JUST BELOW THE BALLOON. THE DEVICE HAD BEEN USED TO EXPAND TWO OF THREE NARROWED URETER LOCATIONS. A STENT WAS LEFT AND THE OPERATION WAS COMPLETED. THE PATIENT EXPERIENCED BLEEDING, AND A URETERAL INJURY WAS ALSO SUSPECTED DUE TO A SUDDEN LEAK OF THE CONTRAST AGENT FROM THE SHAFT PART. ADDITIONAL INFORMATION WAS RECEIVED FROM THE IBC, VIA EMAIL, ON (B)(6) 2018; THE PERSON RECEIVED NO INJURY FROM THE DEVICE, THERE WAS NO ADDITIONAL HOSPITAL STAY, MEDICATION, OR MEDICAL INTERVENTION NEEDED. THE SURGERY HAD BEEN COMPLETED BEFORE THE BREAK WAS FOUND. PER ADDITIONAL INFORMATION FROM THE IBC, VIA EMAIL, ON (B)(6) 2018; THE WEIGHT OF THE PATIENT WAS UNKNOWN AND THE SIZE OF THE X-FORCE DILATION CATHETER WAS 15FR.

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

  MAUDE report 8120083 ↗
• MalfunctionApr 13, 2018Break; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF THE DILATION CATHETER BURST AT 20 ATM. THE COMPLAINANT REPORTED THAT THERE WERE NO MISSING PIECES. THE URETER WAS INSPECTED AND FOUND TO BE CLEAR. THE SURGEON OPENED ANOTHER KIT TO COMPLETE THE PROCEDURE. NO MEDICAL INTERVENTION WAS REPORTED. PER THE SAMPLE RECEIPT, AND CONFIRMATION FROM THE COMPLAINANT, THE DILATION CATHETER BROKE ALONG THE SHAFT OF THE CATHETER AND NOT IN THE BALLOON AS WAS ORIGINALLY REPORTED.

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

  MAUDE report 7429012 ↗
• MalfunctionMay 1, 2017Deflation Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO DEFLATE THE BALLOON OF THE DEVICE. THERE WAS NOT ANY FURTHER INFORMATION FROM THE FACILITY. THERE WAS NO PAIN/INJURY REPORTED ON THE PATIENT. THERE WAS NOT AN ADDITIONAL PROCEDURE REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6533885 ↗