Bard® X-Force® Balloon Dilation Catheter 998804Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10801741052764), received between May 9, 2018 and May 17, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2023Fluid/Blood Leak; Device Handling Problem; Fluid/Blood Leak; Device Handling Problem

  IT WAS REPORTED THAT THE OPERATOR FOUND THAT THE WORKING PRESSURE COULD NOT BE REACHED AND THAT THE PUMP LEAKED WATER WHEN THE USER TRIED TO INFLATE THE BALLOON USING A PUMP. THE BALLOON DILATION CATHETER WAS THEN REMOVED AND REPLACED WITH A NEW ONE TO CONTINUE THE PROCEDURE, CAUSING NO ADVERSE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16949474 ↗
• MalfunctionMar 17, 2023Fracture; Inflation Problem; Fracture; Inflation Problem

  IT WAS REPORTED THAT WHEN INFLATING THE BALLOON DILATION CATHETER DURING OPERATION, THE BALLOON FAILED TO BE INFLATED UNDER SCOPE FOLLOWING WATER INJECTION BY THE ASSISTANT USING A PRESSURE PUMP. THE BALLOON WAS JUDGED TO BE DAMAGED AND THEN REMOVED. A NEW KIT WAS UNPACKED AND USED, CAUSING NO ADVERSE IMPACT ON THE PATIENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 03MAR2023, STATED THE BALLOON COULD NOT BE INFLATED WITH LIQUID INJECTED AND THERE WAS NO BURST. ALSO STATED THAT THE BALLOON WAS INSERTED INTO THE PATIENT, BUT ONCE THE FAILURE OF INFLATION WAS FOUND, THE BALLOON WAS REMOVED FROM THE PATIENT. AND NO HARM OR INJURY CAUSED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16563841 ↗
• MalfunctionFeb 1, 2023Fluid/Blood Leak; Component Misassembled; Fluid/Blood Leak; Component Misassembled

  IT WAS REPORTED THAT WATER LEAKED FROM THE MANOMETER.

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

  MAUDE report 16277506 ↗
• MalfunctionOct 2, 2022Fluid/Blood Leak; Component Misassembled; Fluid/Blood Leak; Component Misassembled

  IT WAS REPORTED THAT THE PRESSURE WAS APPLIED UP TO 30 ATM BY THE INFLATION DEVICE OF THE BALLOON DILATION CATHETER, BUT THE WATER LEAKAGE OCCURRED FROM THE HANDLE PART ON THE WAY AND NO PRESSURE WAS APPLIED . AS PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 22JUN2022, IT WAS UNKNOWN WHETHER 2 INDIVIDUALS (PATIENTS) USED SAME CATHETER FROM SAME LOT. AS PER SAMPLE RECEIVED ON (B)(6) 2022, IT WAS NOTED THAT AN ADDITIONAL INFLATION DEVICE WAS RETURNED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526224 ↗
• MalfunctionJun 24, 2022Fluid/Blood Leak; Component Misassembled; Fluid/Blood Leak; Component Misassembled

  IT WAS REPORTED THAT THE PRESSURE WAS APPLIED UP TO 30 ATM BY THE INFLATION DEVICE OF THE BALLOON DILATION CATHETER, BUT THE WATER LEAKAGE OCCURRED FROM THE HANDLE PART ON THE WAY AND NO PRESSURE WAS APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806469 ↗
• MalfunctionMay 18, 2022Fluid/Blood Leak; Component Misassembled; Fluid/Blood Leak; Component Misassembled

  IT WAS REPORTED THAT THE WATER LEAKED FROM THE HANDLE PART OF THE BALLOON DILATION CATHETER AND PRESSURE DID NOT APPLIED. ANOTHER INFLATION DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429700 ↗
• MalfunctionMar 15, 2022Decrease in Pressure; Component Misassembled; Decrease in Pressure; Component Misassembled

  IT WAS REPORTED THAT WATER LEAKED FROM THE HANDLE PART OF SYRINGE AND THE PRESSURE WAS UNABLE TO BE APPLIED ON BALLOON DILATION CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13773682 ↗
• MalfunctionAug 27, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETEROSCOPIC BALLOON DILATATION CATHETER WAS BROKEN AFTER THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377435 ↗
• MalfunctionApr 8, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PUSHING ROD BURST WHEN THE PRESSURE REACHED 15 ATM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636330 ↗
• MalfunctionNov 17, 2020Inflation Problem; Device Handling Problem; Inflation Problem; Device Handling Problem

  IT WAS REPORTED THAT THE PRESSURE OF THE INFLATION DEVICE DID NOT INCREASE DURING PRETEST.

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

  MAUDE report 10850765 ↗
• MalfunctionMay 9, 2018Leak/Splash

  IT WAS REPORTED THAT DURING URETERAL STENOSIS SURGERY, WHILE INJECTING A CONTRAST AGENT INTO THE BALLOON WITH A PUMP, IT WAS FOUND THAT THE THREE PORTS AND THE PRESSURE PUMP PORT BEGAN TO LEAK WATER.

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

  MAUDE report 7499671 ↗
• MalfunctionMay 9, 2018Leak/Splash

  IT WAS REPORTED THAT DURING THE URETERAL STENOSIS SURGERY ON (B)(6) 2017, THE USER INJECTED A CONTRAST AGENT INTO THE BALLOON WITH A PUMP, AND THE THREE PORTS AND THE PRESSURE PUMP CONNECTION BEGAN TO LEAK.

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

  MAUDE report 7498713 ↗