# FDA recall Z-0640-2018

> **Covidien LLC** · Class II · device recall initiated 2017-09-21.

## 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.

## Reason for recall

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

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0640-2018
- **Recalling firm:** Covidien LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-21
- **Report date:** 2018-02-28
- **Termination date:** 2018-09-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0640-2018

## Citation

> AI Analytics. FDA recall Z-0640-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0640-2018. Source: US FDA. Licensed CC0.

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