FDA Alert: Updated Use Instructions for BD/C.R. Bard Esophagogastric Balloon Tamponade Tubes
The FDA alerts healthcare providers about updated use instructions for BD/C.R. Bard esophagogastric balloon tamponade tubes due to issues with removing plastic plugs, which can cause device damage and delays. BD issued guidance on safe removal and testing.
The FDA is alerting healthcare providers about updated use instructions for BD/C.R. Bard esophagogastric balloon tamponade tubes due to issues with removing plastic plugs. Improper removal can damage the device, delay treatment, and has been linked to two injuries and one death. BD issued guidance in April and May 2025 on how to safely remove the plugs using hemostats and test the balloons before use. Providers should review inventory, follow new instructions, keep backup devices available, and report any issues to BD or the FDA.
