ModerateClass IITerminated

FDA Devices recall · Reported February 28, 2018

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.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 28, 2018. Severity: Moderate. Recall number: Z-0640-2018.

Q: Where was the recalled product distributed?

Distribution: US Nationwide Distribution.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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

Recall #: Z-0640-2018
Affected scope: 17,271 units
Initiated: September 21, 2017

Compiled from official public sources by the publisher. · Updated September 2026

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Covidien LLC recalled GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioni… - a moderate-severity action.

GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioni… was recalled by Covidien LLC in February 28, 2018. Reason: Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positionin…. Check the official notice for the remedy. Verify recall #Z-0640-2018 with the FDA Devices before acting.

The recall

Covidien LLC issued this moderate-severity FDA Devices recall-Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positionin….

Moderate
severity level: 17K units
affected scope: Class II
classification: February 28, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0640-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0640-2018
Date reported	February 28, 2018
Date initiated	September 21, 2017
Recalling firm	Covidien LLC
Firm location	North Haven, CT
Affected scope	17,271 units
Distribution	US Nationwide Distribution

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

17,271 units units affected - limited or regional distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) ✓ This recall

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0640-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 28, 2018. Severity: Moderate. Recall number: Z-0640-2018.

Where was the recalled product distributed? ▼

Distribution: US Nationwide Distribution.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported February 28, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026