FDA Device recall Z-0640-2018
GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatr…
- FDA Device
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatr… by Covidien, citing reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0640-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-21 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | US |
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
Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
Identifiers
| code_info | Product numbers: GPS36 (Pediatric) GPS40 (Adult) Lot codes: E6J0001X E6J0002X E6J0003X E6J0004X E6J0005X E6J…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 E7A0 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0640-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.