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Covidien LLC recalls GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use
Recalled February 28, 2018 · FDA recall Z-0640-2018 · Covidien
Hazard
Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used. · FDA Class II
Units
17,271 units
Sold at
US Nationwide Distribution
Description
Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
Product
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.
Manufacturer(s)
Covidien LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →