Bard® Eagle® Inflation Device 325130Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741067259), received between Feb 5, 2020 and Sep 24, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE ERICS PROCEDURE THE BALLOON INFLATION DEVICE FAILED TO INFLATE PROPERLY BECAUSE CONTRAST LIQUID LEAKAGE FROM THE MANOMETER DURING FLUID INSUFFLATION. (BATCH#BMGWAT01, BATCH#BMGYFM44).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292481 ↗
• MalfunctionFeb 2, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PERCUTANEOUS NEPHROLITHOTOMY WAS PERFORMED ON (B)(6) 2024. AFTER OPENING THE PACKAGE OF BALLOON DILATION CATHETER, THE DOCTOR FOUND THAT THE GAUGE OF THE PRESSURE PUMP WAS DISCONNECTED AND FELL OFF, SO THEY REPLACED IT WITH A NEW PRODUCT AND PERFORMED THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630222 ↗
• MalfunctionAug 24, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON DILATION CATHETER WAS RECEIVED AS IT WAS IN THE PACKAGING, DID NOT WORK, OR WAS BROKEN. IT WAS STATED THAT THE BALLOON DILATION CATHETER WAS FOUND BROKEN IN ITS PACKAGING. IT WAS STATED THAT THE ORIGIN OF THE ISSUE WAS NOT IN TRANSPORT OR SOMETHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611097 ↗
• MalfunctionMar 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE WATER WAS INJECTED INTO THE EAGLE INFLATION BALLOON USING A PRESSURE PUMP FOR INFLATION, THE PRESSURE PUMP LEAKED WATER AT THE PROXIMAL END. THE EVENT INCLUDED AN ADDITIONAL SURGERY OR DRUG THERAPY, AND A NEW PRESSURE PUMP WAS USED. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 03MAR2022, STATED THAT THERE WAS NO ADDITIONAL SURGERY OR DRUG THERAPY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13795703 ↗
• MalfunctionMar 13, 2022Moisture Damage; Decrease in Pressure; Component Misassembled; Moisture Damage; Decrease in Pressure; Component Misassembled

  IT WAS REPORTED THAT PRESSURE ON THE URETERAL DILATION BALLOON CATHETER INDEFLATOR KEPT DECREASING DESPITE OF BRINGING UP TO 30ATM PRESSURE MULTIPLE TIMES. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 26FEB2022, IT WAS STATED THAT THERE WERE NO HOLES OR TEARS IN THE CATHETER BALLOON. THE INFLATION DEVICE SEEMED TO HAVE WATER IN THE PRESSURE INDICATOR FACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13753473 ↗
• MalfunctionOct 11, 2021Burst Container or Vessel; Material Fragmentation; Burst Container or Vessel; Material Fragmentation

  IT WAS REPORTED THAT THE EAGLE INFLATION DEVICE BURST WHEN THE PATIENT WAS IN SURGERY WITH AN X-FORCE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605566 ↗
• MalfunctionFeb 5, 2020Inflation Problem; Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PROCEDURE PREPARATIONS, THE EAGLE INFLATION DEVICE POINTER OF THE PUMP DID NOT WORK PROPERLY. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL 06FEB2020; THE EAGLE INFLATION DEVICE WOULD HOLD PRESSURE BUT THE DIAL POINTER WOULD NOT MOVE.

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

  MAUDE report 9671861 ↗