Bard® X-Force® Balloon Dilation Catheter 998506Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10801741052689), received between May 1, 2017 and Feb 27, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.

• MalfunctionFeb 27, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THEY INFLATED THE BALLOON DILATION CATHETER TO A CERTAIN AMOUNT, BUT IT BURST. ON VISUAL INSPECTION, THE BALLOON PART WAS WRINKLED AND CRUSHED, SO THEY COULD NOT CONFIRM THE DAMAGE. METER PART OF MAIN BODY. THE BASE WAS CRACKED AND CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787742 ↗
• MalfunctionDec 13, 2022Inflation Problem; Component Misassembled; Inflation Problem; Component Misassembled

  IT WAS REPORTED THAT THE INFLATION DEVICE OF THE BALLOON DILATION CATHETER THAT HAD BEEN LOANED TO THE HOSPITAL ON A SHORT-TERM DID NOT WORK PROPERLY. ANOTHER DEVICE OF THE SAME PRODUCT CATALOG NUMBER THAT HAD BEEN PREPARED AS A BACKUP WAS USED AND THE PROCEDURE WAS CONTINUED. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 16DEC2022, STATED THAT PATIENT HAD DIFFICULTY IN INFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968753 ↗
• MalfunctionJun 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE OPERATION, THE CONTRAST MEDIUM LEAKED FROM THE HANDLE OF THE BARD X-FORCE URETERAL BALLOON CATHETER, SO THE USER REFRAINED FROM USING IT. IT SEEMED TO BE HAPPENED IMMEDIATELY AFTER USE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 08JUN2022, STATED THAT IT WAS UNKNOWN WHICH PART OF THE FOLEY CATHETER WAS REFERRED TO AS HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799338 ↗
• MalfunctionJan 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE INFLATION DEVICE OF THE BALLOON DILATION CATHETER WAS BROKEN AT THE BEGINNING OF USE. THE USER STATED THAT THE INFLATION DEVICE GAVE A STRANGE FEELING AND REFRAINED FROM USING IT. THE PATIENT USED THE NEW BALLOON DILATION CATHETER, AS THE USER HAD TWO BOTTLES READY TO GO. THE NEW BALLOON DILATION CATHETER WAS ADDED TO THE PATIENT ON (B)(6) 2021. ONLY THE INFLATION DEVICE WAS COLLECTED. THE METER DID NOT GO UP WHEN THE USER OPERATED IT, AND WATER STARTED LEAKING WHEN PRESSURE WAS APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13168370 ↗
• MalfunctionJan 4, 2022Material Fragmentation; Device Handling Problem; Material Fragmentation; Device Handling Problem

  IT WAS REPORTED THAT THE INFLATION DEVICE OF THE BALLOON DILATION CATHETER WAS BROKEN AT THE BEGINNING OF USE. THE USER STATED THAT THE INFLATION DEVICE GAVE A STRANGE FEELING AND REFRAINED FROM USING IT. THE PATIENT USED THE NEW BALLOON DILATION CATHETER, AS THE USER HAD TWO BOTTLES READY TO GO. THE NEW BALLOON DILATION CATHETER WAS ADDED TO THE PATIENT ON DECEMBER 22ND. ONLY THE INFLATION DEVICE WAS COLLECTED. THE METER DID NOT GO UP WHEN THE USER OPERATED IT, AND WATER STARTED LEAKING WHEN PRESSURE WAS APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13157035 ↗
• MalfunctionOct 28, 2021Fluid/Blood Leak; Device Handling Problem; Fluid/Blood Leak; Device Handling Problem

  IT WAS REPORTED THAT AFTER INSERTING THE DILATION CATHETER, THE CONTRAST MEDIUM WAS INJECTED BY MANUAL PUSHING. ALSO, IT WAS STATED THAT WHEN THE PRESSURE WAS APPLIED BY TURNING THE INFLATION DEVICE IT WAS LOCKED, THE CONTRAST MEDIUM LEAKED FROM THE AREA BETWEEN THE PRESSURE GAUGE OF THE INFLATION DEVICE AND THE SYRINGE. PRESSURE WAS NOT APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12714649 ↗
• MalfunctionSep 9, 2020Partial Blockage; Material Rupture; Partial Blockage

  IT WAS REPORTED THAT THE PRESSURE SUDDENLY DROPPED FROM THE CATHETER DUE TO THE BALLOON BURST. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE IBC ON 21AUG2020, IT WAS UNKNOWN WHETHER THE BALLOON BURST OCCURRED AND PER NOTIFICATION RECEIVED VIA INVESTIGATOR ON 01JAN2021, BASED ON THE SUPPLIER EVALUATION IT WAS FOUND THAT THE REPORTED EVENT ALIGNS MORE TO A INFLATION ISSUE DUE TO A DRIED CONTRAST MEDIUM.

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

  MAUDE report 10512312 ↗
• MalfunctionDec 3, 2019Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE DILATATION CATHETER WAS FOUND TO HAVE A DAMAGED BALLOON UPON REMOVAL OF THE CATHETER. THE USER NOTED THE METER DID NOT GO UP AS USUAL WHEN THE EXPANSION FLUID WAS INJECTED INTO THE DEVICE, AND THUS REMOVED THE CATHETER TO FIND A BURST BALLOON.

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

  MAUDE report 9403462 ↗
• MalfunctionDec 3, 2019Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  IT WAS REPORTED THAT THE DILATATION CATHETER WAS FOUND TO HAVE A DAMAGED BALLOON UPON REMOVAL OF THE CATHETER. THE USER NOTED THE METER DID NOT GO UP AS USUAL WHEN THE EXPANSION FLUID WAS INJECTED INTO THE DEVICE, AND THUS REMOVED THE CATHETER TO FIND A BURST BALLOON.

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

  MAUDE report 9403273 ↗
• MalfunctionSep 16, 2019Break; Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE DILATATION CATHETER WAS FOUND TO HAVE A DAMAGED BALLOON UPON REMOVAL OF THE CATHETER. THE USER NOTED THAT THE METER DID NOT GO UP AS USUAL WHEN THE EXPANSION FLUID WAS INJECTED INTO THE DEVICE, AND THUS REMOVED THE CATHETER AND FOUND A BURST BALLOON.

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

  MAUDE report 9072617 ↗
• MalfunctionMar 20, 2019Inflation Problem; Pressure Problem; Inflation Problem

  IT WAS REPORTED THAT THE PRESSURE WAS UNABLE TO RISE FROM 6 ATM WITH AN INFLATION DEVICE.

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

  MAUDE report 8438036 ↗
• MalfunctionSep 27, 2018Break; Inflation Problem

  IT WAS REPORTED THAT THE INFLATION DEVICE ON THE URETERAL CATHETER WAS BROKEN PRIOR TO USE.

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

  MAUDE report 7913917 ↗
• MalfunctionSep 19, 2018Positioning Problem; Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT IT WAS DIFFICULT TO MOVE THE METER DURING USE. IT WAS LATER REPORTED FROM THE IBC VIA EMAIL ON SEPTEMBER 4TH, 2018 THAT THE NEEDLE OF THE INFLATION DEVICE WAS NOT MOVING WHEN THE USER TRIED TO MOVE THE INFLATION VALVE.

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

  MAUDE report 7890182 ↗
• MalfunctionAug 22, 2017Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS UNABLE TO BE INFLATED WHILE IN THE PATIENT.

  Patient problems: No Information

  MAUDE report 6811733 ↗
• MalfunctionMay 1, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT FLUID LEAKED OUT OF THE BALLOON WHEN ATTEMPTING TO INFLATE THE DEVICE. ANOTHER DEVICE OF THE SAME TYPE WAS USED FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6533817 ↗