This recall involves updating the Instructions for using these devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product
The FDA is aware that BD and their subsidiary C.R. Bard Urology and Critical Care have issued a letter to affected customers that all lots of certain esophagogastric balloon tamponade tubes have updated use instructions:
Device Name |
Model Number |
UDI-DI |
| Bard Minnesota Four Lumen Esophagogastric Tamponade Tube | 0092220 | 00801741076824 |
| Bard Blakemore Esophageal Nasogastric Tube | 0092100 | 00801741076800 |
| Bard Blakemore Esophageal Nasogastric Tube (Child) | 0092110 | 00801741076817 |
| Bard Blakemore Esophageal Nasogastric Tube (Intermediate) | 0092300 | 00801741076831 |
| Bard Single Intragastric Linton Balloon Tube | 0092740 | 00801741076848 |
What to Do
These devices are used in critical and emergency situations. Users should review and follow the updated instructions for removal of the plastic plugs provided below prior to continued use.
- On April 17, BD sent all affected customers a letter with recommended actions. On May 19, 2025, a follow-up letter was sent with more detailed instructions:
- Follow the Plastic Plug Removal Instructions:
- Before use with patients, prepare the device by removing the plastic plugs and set them aside to remain with the device.
- To aid in plug removal, fully open the 5” Straight Smooth Jaw Hemostats and insert one hemostat jaw between the plug and the rubber lumen. While the hemostat jaw is inserted, rotate the jaw around the plug’s circumference as seen in the image below. Remove the hemostat, then the plug.
- Following removal of the plastic plugs, test the balloons for evidence of air leaks prior to proceeding with the remaining steps required for placement as described in the original instructions for use (IFU).
- Check all inventory locations within your institution for the affected product. Post the provided notice where the devices are stored.
- Store 5” Straight Smooth Jaw Hemostat with the affected devices for immediate availability to be used for plastic plug removal.
- Have secondary balloon tamponade devices available for immediate replacement if the first device is damaged during plastic plug removal.
- Share the provided notice with any users of the product within your facilities or with any interfacility users where product was transferred, to ensure they are also aware of this Medical Device Correction.
- Follow the Plastic Plug Removal Instructions:
- Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Updated Use Instructions
BD has become aware that users are sometimes unable, or find it difficult, to remove the plastic plugs from the rubber lumen in order to inflate the gastric and/or esophageal balloons. In some cases, the devices may become damaged during removal of the plastic plugs in which a replacement device will be needed.
Potential health consequences include delay in diagnosis or delay in treatment which may result in the onset or prolongation of hypotension and its potential short and long-term complications, up to and including death. This issue may also result in additional and unexpected diagnostic and medical/surgical interventions to manage the patient’s bleeding.
BD has reported two serious injuries and one death associated with this issue.
Device Use
Esophagogastric balloon tamponade tubes are devices made of flexible tubing used to help identify and control bleeding from enlarged veins in the esophagus and stomach. The tubes use pressure from balloons to compress an area to help control bleeding, and suction ports to remove fluids from the esophagus and stomach.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact BD at productcomplaints@bd.com or 1-844-823-5433 and say “product complaints” when prompted.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
