Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning Recalled by Covidien LLC Due to Reports of gastric or esophageal perforation occurring in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Covidien LLC directly.
Affected Products
GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.
Quantity: 17,271 units
Why Was This Recalled?
Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Covidien LLC
Covidien LLC has 248 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report