Covidien LLC recalls GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in…

Recall date

September 21, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0640-2018

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

US Nationwide Distribution

Why it was recalled

Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.