Bard® X-Force® Balloon Dilation Catheter 998004Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10801741052795), received between Aug 23, 2017 and Sep 30, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951852 ↗
• MalfunctionSep 11, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741622 ↗
• MalfunctionSep 17, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THERE WAS DIFFICULTY IN DRAINING STERILIZED WATER FROM THE FOLEY CATHETER DURING PRE-TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073649 ↗
• MalfunctionApr 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE WATER LEAKAGE OCCURRED FROM THE TIP OF THE FOLEY CATHETER BALLOON DURING THE THIRD BALLOON EXPANSION AS THE BALLOON WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873634 ↗
• MalfunctionAug 10, 2023Material Fragmentation; Solder Joint Fracture; Material Fragmentation; Solder Joint Fracture

  IT WAS REPORTED THAT WHEN UNPACKING THE BALLOON DILATION CATHETER DURING OPERATION, THE PUMP WAS FOUND RUPTURED AND DAMAGED. THIS CAUSED NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497923 ↗
• MalfunctionApr 27, 2023Fracture; Component Misassembled; Fracture; Component Misassembled

  IT WAS REPORTED THAT PRESSURE COULD NOT BE APPLIED. PRESSURE WAS GIVEN TO THE DEVICE FOR THE DILATION OF URETHRA, BUT NO PRESSURE WAS APPLIED. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 09APR2023, THE BASE OF THE METER PART WAS CRACKED AND DETACHED FROM THE MAIN BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822488 ↗
• MalfunctionApr 26, 2023Material Fragmentation; Component Misassembled; Material Fragmentation; Component Misassembled

  IT WAS REPORTED THAT MANOMETER SECTION OF INFLATION DEVICE WAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16814593 ↗
• MalfunctionJan 28, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE INFLATION DEVICE MEMORY DID NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261568 ↗
• MalfunctionDec 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CAP ON THE TIP OF THE BALLOON DILATATION CATHETER WAS DEFORMED OR STUCK, AND IT WAS UNABLE TO COME OFF. PER FOLLOW UP INFORMATION RECEIVED ON 25NOV2021, IT WAS UNKNOWN IF IT WAS DEFORMED OR STUCK. IT WAS REPORTED THAT THE CAP WOULD NOT COME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954534 ↗
• MalfunctionSep 29, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER THE INSERTION INTO THE URETHRA, DILATATION WAS ATTEMPTED, BUT COULD NOT BE ACHIEVED UNDER FLUOROSCOPIC GUIDANCE AND THE CATHETER WAS REMOVED FROM THE BODY. AFTERWARDS, IT WAS FOUND THAT THERE WAS WATER LEAKAGE FROM THE BALLOON WHEN CHECKED UNDER DIRECT VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546636 ↗
• MalfunctionJun 20, 2019Use of Device Problem; Fluid/Blood Leak; Use of Device Problem

  IT WAS REPORTED THAT WATER LEAKAGE OCCURRED FROM THE BACKSIDE OF THE DEVICE WHEN PRESSURE WAS APPLIED.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8716760 ↗
• MalfunctionNov 20, 2018Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON ON THE DILATION CATHETER DID NOT DEFLATE ALL THE WAY. THE SCOPE HAD TO BE TAKEN OUT FOR THE DILATOR TO BE REMOVED.

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

  MAUDE report 8088736 ↗
• MalfunctionJan 30, 2018Inflation Problem

  IT WAS REPORTED THAT THE DILATING PRESSURE COULD NOT BE APPLIED DUE TO THE BALLOON COULD NOT BE INFLATED DURING A PRETEST. PER SAMPLE EVALUATION, VISUAL INSPECTION NOTED THAT THE SHAFT OF THE CATHETER APPEARED TO BE DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7229272 ↗
• MalfunctionDec 12, 2017Inflation Problem

  IT WAS REPORTED THAT THE DILATING PRESSURE COULD NOT BE APPLIED, BECAUSE THE BALLOON COULD NOT BE INFLATED DURING A PRETEST.

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

  MAUDE report 7107875 ↗
• MalfunctionAug 23, 2017Deflation Problem

  IT WAS REPORTED THAT AN X-FORCE U30 BALLOON DILATION CATHETER COULD NOT BE DEFLATED. THE DOCTOR DEFLATED THE BALLOON LITTLE BY LITTLE WITH A SYRINGE, BECAUSE HE COULD NOT DEFLATE IT WITH AN INFLATION DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6815097 ↗