Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
In short: a Sengstaken-Blakemore (SB) tube is a multi-lumen tube with a gastric balloon and an esophageal balloon, used as a temporary measure to control bleeding from the esophagus or stomach, most classically bleeding esophageal varices. It is an emergency device that clinicians now use rarely, and FDA lists it under the product code FCB with the name “bag, hemostatic”. This guide is for clinic and hospital staff, supply and procurement readers and students who need to know what the device is, how it differs from related tubes, and how it is regulated.
What is a Sengstaken-Blakemore tube?
The SB tube was introduced in the 1950s. A 2025 review in the World Journal of Critical Care Medicine describes it as a multi-lumen tube “featuring esophageal and gastric balloons” that applied mechanical pressure to control bleeding and gave a temporary solution until more definitive treatment could be used. Its classic purpose is bleeding from esophageal varices, and a 2014 case report in Gastroenterology Report calls it a rescue therapy in acute gastro-esophageal variceal bleeding.
Who uses it: emergency, critical care and gastroenterology clinicians, with supply staff stocking it as a single-purpose emergency item.
How it is built
The 2025 review describes the SB tube as a single-use tube introduced through the mouth or nose with three parts: a gastric balloon, an esophageal balloon and a gastric suction port. The review notes the gastric suction port can be used to empty blood residue from the stomach, which allows better visualization. The tube’s three-part layout is easiest to compare with the lumens and connectors described in parts of a nasogastric tube.
Types and variants
| Tube | Parts described in the source | Key difference |
|---|---|---|
| Sengstaken-Blakemore tube | Gastric balloon, esophageal balloon, gastric suction port | The original design; suction is gastric only |
| Minnesota tube (modified SB tube) | The SB design plus an additional lumen | The additional lumen is used to aspirate the esophagus |
Source for both rows: Kogilathota Jagirdhar et al., World J Crit Care Med, 2025 (PMC12304998), checked 2026-10-30.
Regulatory classification
FDA’s Product Classification database lists product code FCB under the device name “bag, hemostatic”, regulation number 21 CFR 876.5980, regulation description “Gastrointestinal tube and accessories”, device class 2, review panel Gastroenterology/Urology. The database entry has no separate definition text. The FDA device name does not include the words Sengstaken or Blakemore, so the product code and regulation number are the identifiers to use when looking the device up in FDA records. For how class 2 devices reach the market, see FDA 510(k) premarket notification, 510(k) versus PMA and the overview of FDA medical device classification.
Safe use and handling basics
- Temporary measure. The 2025 review describes it as a temporary solution until more definitive treatments can be used.
- Known complications. The sources list aspiration pneumonia, esophageal perforation, mucosal necrosis and respiratory compromise from tracheal compression. The 2025 review states the complication rate can be as high as 40%.
Manufacturer instructions for use, hospital protocol and clinician training govern placement and monitoring. This page does not give those steps.
Common mistakes
- Treating it as a routine item. The 2025 review documents a decline in use as endoscopic and other modern techniques replaced it, and a 2026 Cureus paper calls balloon tamponade a rarely performed emergency procedure for which trainees get little hands-on exposure.
- Searching by common name only. The FDA record is “bag, hemostatic”, code FCB (see above).
- Treating it as definitive treatment. Both sources describe it as a bridge to definitive therapy.
Frequently asked questions
What is a Sengstaken-Blakemore tube used for?
It is used as a temporary measure to control bleeding from esophageal varices,, and a 2014 case report describes its use in one case of non-variceal esophageal bleeding that endoscopic treatment had not controlled. It is described as a bridge until definitive treatment is possible.
What is the difference between a Sengstaken-Blakemore tube and a Minnesota tube?
Per the 2025 review, the Minnesota tube is a modified SB tube with an additional lumen to aspirate the esophagus.
How is it classified by FDA?
Product code FCB, “bag, hemostatic”, 21 CFR 876.5980, class 2 (FDA Product Classification database, checked 2026-10-30).
Sources
- FDA Product Classification database, product code FCB: accessdata.fda.gov, checked 2026-10-30; openFDA classification record last updated 2026-10-19.
- Kogilathota Jagirdhar GS et al., “Decline of the Sengstaken-Blakemore tube: A review of shifting practices in gastrointestinal hemorrhage management,” World J Crit Care Med, 2025: PMC12304998, checked 2026-10-30.
- “Sengstaken-Blakemore tube for non-variceal distal esophageal bleeding refractory to endoscopic treatment: a case report and review of the literature,” Gastroenterol Rep, 2014: PMC4219138, checked 2026-10-30.
- Poloway D et al., “Ballooning to Success: A Novel and Reproducible Sengstaken-Blakemore Model for Educating Emergency Medicine Trainees,” Cureus, 2026: PMC13322749, checked 2026-10-30.
