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GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning syste...

FDA Device Recall #Z-0640-2018 — Class II — September 21, 2017

Recall Summary

Recall Number Z-0640-2018
Classification Class II — Moderate risk
Date Initiated September 21, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Covidien LLC
Location North Haven, CT
Product Type Devices
Quantity 17,271 units

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.

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

Product numbers: GPS36 (Pediatric) GPS40 (Adult) Lot codes: E6J0001X E6J0002X E6J0003X E6J0004X E6J0005X E6J0006X E6J0007X E6J0008X E6J0009X E6J0010X E6J0011X E6J0012X E6J0013X E6J0014X E6J0015X E6J0016X E6J0017X E6J0018X E6J0019X E6J0020X E6K0001X E6K0002X E6K0003X E6K0004X E6K0005X E6K0006X E6K0007X E6K0008X E6K0009X E6K0010X E6K0011X E6K0012X E6K0013X E6K0014X E6K0015X E6K0016X E6K0017X E6K0018X E6K0019X E6K0020X E6K0021X E6K0022X E6K0023X E6K0024X E6K0025X E6L0001X E6L0002X E6L0003X E6L0004X E6L0005X E6L0006X E6L0007X E6L0008X E6L0009X E6L0010X E6L0011X E6L0012X E6L0013X E6L0014X E6L0015X E6L0016X E6L0017X E6L0018X E6L0019X E6L0020X E6L0021X E6M0001X E6M0002X E6M0003X E6M0004X E6M0005X E6M0006X E6M0007X E6M0008X E6M0009X E6M0010X E6M0011X E6M0012X E6M0013X E6M0014X E7A0001X E7A0002X E7A0003X E7A0004X E7A0005X E7A0006X E7A0007X E7A0008X E7A0009X E7A0010X E7A0011X E7A0012X E7A0013X E7A0014X E7A0015X E7A0016X E7A0017X E7A0018X E7A0019X E7B0001X E7B0002X E7B0003X E7B0004X E7B0005X E7B0006X E7B0007X E7B0008X E7B0009X E7B0010X E7B0011X E7B0012X E7B0013X E7B0014X E7B0015X E7C0001X E7C0002X E7D0001X E7D0002X E7D0003X E7D0004X E7D0005X E7D0006X E7D0007X E7D0008X E7D0009X E7D0010X E7E0001X E7E0002X E7E0003X

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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