Bard® Eagle® Inflation Device 325110Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741067242), received between Oct 10, 2019 and Oct 9, 2024 — classified as 11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STRICTURE WAS ENCOUNTERED DURING URETERAL STONE SURGERY USING A URETEROSCOPIC BALLOON DILATION CATHETER, WHICH WAS UNPACKED WITH THE PRESSURIZED PUMP FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT SET OF BALLOONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406513 ↗
• MalfunctionJun 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UPON OPENING THE BALLOON DILATION CATHETER, IT WAS FOUND THAT THE PRESSURE PUMP GAUGE WAS DAMAGED AND COULD NOT BE USED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19561316 ↗
• MalfunctionMay 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BEFORE THE URETERAL STRICTURE DILATION SURGERY, WHEN THE EAGLE INFLATION DEVICE WAS OPENED AND READY TO BE USED, IT WAS OBVIOUS THAT THE PRESSURE PUMP GAUGE WAS BROKEN, AND THE PRESSURE WAS SLOWLY PRESSURIZED WITHOUT ANY CHANGE IN THE PRESSURE VALUE AND THE SOLUTION WAS CHANGE THE SET OF BALLOONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19269132 ↗
• MalfunctionApr 10, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE DOCTOR WAS PERFORMING URETERAL STRICTURE DILATION SURGERY, THE RELEVANT PREPARATIONS FOR THE OPERATION HAD BEEN COMPLETED, AND THE SURGICAL CONSUMABLES WERE OPENED STEP BY STEP ACCORDING TO THE SURGICAL STEPS, AND AFTER THE U30 WAS OPENED, IT WAS FOUND THAT THE PRESSURE PUMP GAUGE FELL OFF AND COULD NOT BE USED. THE DOCTOR REOPENED A SET OF U30S TO COMPLETE THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080237 ↗
• MalfunctionNov 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EAGLE INFLATION DEVICE WAS NOT WORKING AT ALL AND WAS LEAKING WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169806 ↗
• MalfunctionOct 31, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UPON UNPACKING THE PACKAGE DURING THE OPERATION, IT WAS FOUND THAT THE PUMP OF THE BALLOON DILATION CATHETER HAD BEEN BROKEN AND DAMAGED, AND THEN IT WITHDREW AND REPLACED WITH A NEW PACKAGING PRODUCT TO CONTINUE THE OPERATION, WITHOUT ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039287 ↗
• MalfunctionJul 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRESSURIZATION PUMP FOR THE X-FORCE U30 URETEROSCOPIC BALLOON DILATION CATHETER LEAKED WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258444 ↗
• MalfunctionSep 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRESSURE PUMP IN THE EAGLE INFLATION DEVICE LEAKED WATER WHEN IN USE BY THE CLINICIAN. IT WAS MENTIONED THAT A NEW PRESSURE PUMP WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419689 ↗
• MalfunctionOct 2, 2020Device Handling Problem; Inflation Problem; Device Handling Problem

  IT WAS REPORTED THAT THE INFLATION DEVICE PUMP TO INFLATE THE BALLOON DID NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10623201 ↗
• MalfunctionFeb 5, 2020Break; Inflation Problem; Leak/Splash; Inflation Problem

  IT WAS REPORTED THAT THE EAGLE INFLATION DEVICE WAS FOUND TO BE DAMAGED UPON OPENING THE PACKAGE. THE PUMP LEAKED DURING PRETEST.

  Patient problems: No Patient Involvement

  MAUDE report 9671927 ↗
• MalfunctionOct 10, 2019Fluid/Blood Leak; Inflation Problem; Use of Device Problem; Use of Device Problem

  IT WAS REPORTED LIQUID WAS LEAKING FROM THE DEVICE. THE BALLOON DID NOT INFLATE.

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

  MAUDE report 9174758 ↗