FDA-Device2018-02-28Class II
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.
Covidien LLC
Hazard
Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
Sold states
US Nationwide Distribution
Affected count
17,271 units
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0640-2018Don't want to check this manually?
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