Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 provid — recall Z-0640-2018

U.S. FDA — Device Enforcement · United States · 2017-09-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0640-2018
Date of alert: 2017-09-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Covidien LLC
Product category: device
Product type: Devices

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

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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