Bard® X-Force® Balloon Dilation Catheter 998606Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10801741052719), received between Jul 11, 2017 and Apr 28, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT DURING THE SECOND DILATION ON THE SAME PROCEDURE, THE BALLOON DILATION CATHETER PRESSURE PUMP SHOWED THAT IT COULD NOT REACH THE SPECIFIED PRESSURE. A LEAK WAS FOUND, AND AFTER REPLACING THE BALLOON, THE DILATION WAS SUCCESSFULLY COMPLETED. THE USER WAS EXPOSED TO BODILY FLUID.

  Patient problems: Exposure to Body Fluids

  MAUDE report 25019148 ↗
• InjuryJul 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT AFTER PRESSURIZING TO 25ATM, THE BALLOON DILATION CATHETER LOST PRESSURE, AND IT WAS FOUND THAT THE BALLOON HAD BURST AND LEAKED. THE BALLOON WAS REPLACED AND REUSED. THE USER WAS EXPOSED TO HAZARDOUS MATERIALS, BLOOD OR BODY FLUIDS.

  Patient problems: Exposure to Body Fluids

  MAUDE report 22564499 ↗
• MalfunctionDec 26, 2023Disconnection; Use of Device Problem; Disconnection; Use of Device Problem

  IT WAS REPORTED THAT THE BALLOON DILATION CATHETER PUMP WAS DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393475 ↗
• MalfunctionSep 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BALLOON LEAKED WATER IN THE BALLOON DILATION CATHETER WHEN BEING FILLED WITH WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17692146 ↗
• MalfunctionSep 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRESSURE PUMP OF THE BALLOON DILATATION CATHETER LEAKED WATER. THE AFFECTED PRODUCT WAS NOT USED ON A PATIENT. STATED THAT THERE WAS A SURGICAL DELAY AND PROLONGED SURGERY.

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

  MAUDE report 17669937 ↗
• MalfunctionMay 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SURGICAL NURSE FOUND THAT THE BALLOON OF THE BALLOON DILATION CATHETER LEAKED WATER PRIOR TO USE FOLLOWING UNPACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16993113 ↗
• MalfunctionMay 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN PREPARING THE URETER STENOSIS DILATATION WITH BALLOON, THE CUSTOMER INFLATED THE BALLOON USING A PRESSURE PUMP AND FOUND THAT THE BALLOON LEAKED WATER. THIS MADE THE PRODUCT UNUSABLE AND THE CUSTOMER IMMEDIATELY DISCONTINUED THE USE OF THE PRODUCT, CAUSING NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886189 ↗
• MalfunctionApr 3, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON OF THE BALLOON DILATION CATHETER WAS FOUND TO BE LEAKING WATER DURING INFLATION AND PRE-FLUSHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16664448 ↗
• MalfunctionMar 7, 2023Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  IT WAS REPORTED THAT WHEN PREPARING THE BALLOON FOR DILATATION DURING OPERATION, THE ASSISTANT FOUND THAT WATER COULD NOT BE INJECTED INTO THE PRESSURE PUMP AND JUDGED THAT IT MAY BE DUE TO BALLOON DAMAGE. THE SPARE KIT WAS THEREFORE UNPACKED TO PROCEED TO THE OPERATION. THEREAFTER, THE OPERATION WAS DONE SUCCESSFULLY, CAUSING NO ADVERSE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495871 ↗
• MalfunctionAug 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DILATION CATHETER BALLOON LEAKED. THE OPERATION COULD NOT BE COMPLETED BECAUSE THE PRESSURE COULD NOT BE APPLIED WHEN THE DOCTOR EXAMINED THE CONSUMABLES USED BEFORE THE PATIENT UNDERWENT URETERAL DILATATION ON THE AFTERNOON OF (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388172 ↗
• MalfunctionJun 2, 2021Gas/Air Leak; Device Handling Problem; Gas/Air Leak; Device Handling Problem

  IT WAS REPORTED THAT THE DESIRED PRESSURE WAS NOT REACHED DUE TO AIR LEAK IN THE PUMP OF THE BALLOON DILATION CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922298 ↗
• MalfunctionJun 2, 2021Fracture; Device Handling Problem; Fracture; Device Handling Problem

  IT WAS REPORTED THAT THE PUMP HEAD OF THE BALLOON DILATION CATHETER WAS FOUND TO BE CRACKED UPON OPENING THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921499 ↗
• MalfunctionMay 10, 2021Material Fragmentation; Device Handling Problem; Material Fragmentation; Device Handling Problem

  IT WAS REPORTED THAT THE HEAD OF THE PUMP WAS FOUND TO BE RUPTURED WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802449 ↗
• MalfunctionFeb 8, 2021Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BALLOON OF THE X-FORCE U30 URETEROSCOPIC BALLOON DILATION CATHETER WAS UNABLE TO BE INFLATED BY THE WATER INJECTION AS THE BALLOON WAS DAMAGED SINCE THE DEVICE WAS UNUSABLE.

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

  MAUDE report 11292314 ↗
• MalfunctionOct 2, 2020Inflation Problem

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS DIFFICULT TO INFLATE. THE SHAFT AREA NEAR THE BALLOON ALLEGEDLY WAS INFLATED. THE DEVICE WAS NOT USED.

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

  MAUDE report 10620383 ↗
• MalfunctionAug 12, 2020Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT A CATHETER WAS BURST ALL OF A SUDDEN IN THE PROCESS OF PROCEDURE. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL FROM IBC, THERE WERE NO MISSING PIECES TO THE BALLOON.

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

  MAUDE report 10398537 ↗
• MalfunctionJun 9, 2020Component Missing

  IT WAS REPORTED THAT THE FOLDER ON THE DILATION CATHETER WAS MISSING AFTER OPENING THE PRODUCT DURING THE PROCEDURE. AS A RESULT, THE BALLOON COULDN'T BE RESTORED WHEN THE FIRST EXPANSION FAILED AND A SECOND EXPANSION WAS REQUIRED. IT WAS LATER CLARIFIED VIA EMAIL ON 2 JUNE 2020 FROM IBC REPRESENTATIVE, THAT THE USER WAS REFERRING TO THE REFOLDING TOOL THAT WAS MISSING FROM THE PACKAGE.

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

  MAUDE report 10135543 ↗
• MalfunctionApr 14, 2020Inflation Problem; Decrease in Pressure

  IT WAS REPORTED THAT AFTER PERFORMING THE DILATION PROCEDURE TWICE, THE DILATION CATHETER BALLOON WOULD NOT FIRMLY INFLATE FOR A THIRD TIME. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL 30MAR2020, THE PROCEDURE WAS COMPLETED AND ON TIME.

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

  MAUDE report 9957172 ↗
• MalfunctionMar 11, 2020Burst Container or Vessel

  IT WAS REPORTED THAT THE X-FORCE DILATION CATHETER BALLOON BURST DURING INSTALLATION. THE PATIENT WAS NOT INJURED. PER ADDITIONAL INFORMATION FROM THE (B)(6) VIA EMAIL 09MAR2020, THERE WERE NO MISSING PIECES TO THE BURST BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9820377 ↗
• MalfunctionFeb 10, 2020Pressure Problem; Device Handling Problem; Noise, Audible; Device Handling Problem

  IT WAS REPORTED THAT THE PRESSURE COULD NOT INCREASE ON THE X-FORCE DEVICE. REPORTEDLY, WHEN THE INFLATION DEVICE WAS CONNECTED TO THE X-FROCE AND THE HANDLE WAS ROTATED, A NOISE OCCURRED AND THE PRESSURE COULD NOT INCREASE. IT WAS LATER REPORTED FROM THE INTERNATIOANAL BUSINESS CENTER VIA EMAIL 13FEB2020 THAT IT WAS IN FACT THE EAGLE INFLATION DEVICE NOT FUNCTIONING CORRECTLY.

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

  MAUDE report 9687212 ↗
• MalfunctionAug 28, 2019Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT FLUID LEAKED FROM NEAR THE BALLOON ON THE 1ST DAY OF USE.

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

  MAUDE report 8940562 ↗
• MalfunctionMar 15, 2019Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings; Leak/Splash

  IT WAS REPORTED THAT UPON THE PRE-TEST, THE PUMP COULD NOT BE USED.

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

  MAUDE report 8424187 ↗
• MalfunctionMar 15, 2019Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS URETERAL BALLOON PUMP LEAKAGE DURING PRETEST.

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

  MAUDE report 8424183 ↗
• MalfunctionNov 29, 2018Inflation Problem; Inflation Problem; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE DID NOT HOLD PRESSURE.

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

  MAUDE report 8114442 ↗
• MalfunctionAug 6, 2018Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT THE SHAFT OF THE URETERAL CATHETER WAS RUPTURED WHEN THE WATER WAS PRESSURIZED TO 20 ATMOSPHERES. THE PATIENT UNDERWENT URETERAL STRICTURE SURGERY AT 10:02 AM ON (B)(6) AND THE OUTER PACKAGING OF THE PRODUCT WAS CHECKED BEFORE USE. THERE WAS NO ABNORMALITY IN THE OUTER PACKAGING.

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

  MAUDE report 7752234 ↗