BD Esophagogastric Balloon Tamponade Tube Recall
BD Esophagogastric Balloon Tamponade Tube Recall
A serious medical device recall has recently been issued by Becton, Dickinson and Company (BD) and its subsidiary C.R. Bard concerning several models of esophagogastric balloon tamponade tubes. These life-saving devices, used in emergency situations to control gastrointestinal bleeding, now carry increased risks due to problems with removing plastic plugs from the rubber lumen. The U.S. Food and Drug Administration (FDA) has classified this correction as a Class I recall—the most serious type—indicating that use of the device without following new instructions may cause injury or death. FDA Source
As a firm dedicated to patient safety and consumer protection, KBD Attorneys is monitoring this recall closely. Our team is committed to helping those affected by dangerous or defective medical devices and ensuring that manufacturers are held accountable when products fail to meet safety standards.
What Devices Are Affected?
The recall applies to all lots of the following esophagogastric balloon tamponade tubes:
- Bard Minnesota Four Lumen Esophagogastric Tamponade Tube (Model 0092220)
- Bard Blakemore Esophageal Nasogastric Tube (Model 0092100)
- Bard Blakemore Esophageal Nasogastric Tube (Child) (Model 0092110)
- Bard Blakemore Esophageal Nasogastric Tube (Intermediate) (Model 0092300)
- Bard Single Intragastric Linton Balloon Tube (Model 0092740)
Each of these models has an associated Unique Device Identifier (UDI), allowing users to check for affected units via the FDA’s AccessGUDID database.
The Issue: Difficulty Removing Plastic Plugs
BD reported that users are often unable to remove the plastic plugs from the rubber lumen—a crucial step required to inflate the gastric and/or esophageal balloons used to stop bleeding. When these plugs cannot be removed properly, the device may become damaged, rendering it unusable in an emergency situation. In worst-case scenarios, the need to replace a device mid-procedure can result in fatal delays.
So far, two serious injuries and one death have been reported due to this malfunction.
Updated Instructions for Use
BD issued an initial customer letter on April 17, 2025, followed by a more detailed communication on May 19, 2025. Healthcare providers are now urged to follow specific steps to safely remove the plastic plugs:
- Fully open a 5” Straight Smooth Jaw Hemostat.
- Insert one jaw between the plastic plug and the rubber lumen.
- Rotate the jaw around the plug’s circumference.
- Remove the hemostat and then carefully remove the plug.
- Test the balloons for air leaks prior to use.
Facilities must also:
- Store hemostats with the affected devices.
- Have secondary tamponade devices available.
- Share the recall information across their institutions and any other locations where the devices are used.
Health Risks and Consequences
The inability to use these devices correctly during an emergency can result in serious complications, including:
- Delay in diagnosis or treatment
- Onset or worsening of hypotension
- Prolonged hospital stays
- Increased need for invasive interventions
- Death
These risks make it absolutely essential that medical professionals and institutions take immediate action in response to the updated instructions.
What Should Healthcare Providers Do?
If you work in a facility where these devices are used:
- Check all inventory for the affected products.
- Train staff on the updated removal technique.
- Report any adverse events to the FDA MedWatch system.
- Contact BD at productcomplaints@bd.com or 1-844-823-5433 for additional support.
KBD Attorneys Is Here to Help
At KBD Attorneys, we understand the critical role medical devices play in emergency care—and how devastating it can be when these devices fail. We are actively monitoring this recall and advocating for patients and families affected by the BD esophagogastric tube correction.
If you or a loved one suffered complications due to this device, you may have legal options. KBD Attorneys can:
- Investigate whether your case is linked to this recall
- Assist in obtaining medical records and device documentation
- Connect you with expert medical and legal advisors
- Pursue compensation for medical expenses, pain and suffering, and other damages
Why Choose KBD Attorneys?
KBD Attorneys has built a national reputation for litigating complex medical device cases. We are passionate about holding negligent manufacturers accountable and ensuring that healthcare providers and patients have access to safe, effective tools.
Our mission is simple: to protect the most vulnerable, to fight for justice, and to never back down when lives are at stake. We believe no patient should suffer harm because a device didn’t work as intended.
Stay Informed, Stay Protected
We encourage all healthcare providers, patients, and family members to stay informed about this evolving situation. Visit the FDA’s recall page here for the most current updates.
If you have questions about your legal rights or suspect that a medical device has caused harm, contact KBD Attorneys today for a free consultation. We are here to stand with you—and to hold manufacturers accountable when their products put lives at risk.
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