GastriSail" Gastric Positioning Device Product Usage: The GastriSail… — Class II medical device recall Z-0640-2018
Terminated recall by Covidien LLC, reported 2018-02-28, distributed nationwide. Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning
| Recall number | Z-0640-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2017-09-21 |
| Classified | 2018-02-20 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2018-09-26 |
| Distributed | Nationwide (US) |
| Quantity | 17,271 units |
| Lot numbers | 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 and 89 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0640-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.