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.
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:
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.
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.
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.
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact BD at [email protected] or 1-844-823-5433 and say "product complaints" when prompted.
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.
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.