Covidien GastriSail Gastric Positioning Device Recall: Risk of Perforation
Covidien recalls GastriSail gastric positioning devices due to reports of gastric or esophageal perforation during use in bariatric surgery. Affected models include GPS36 (pediatric) and GPS40 (adult) with specific lot codes.
Recall notice
Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
Contact the company
What happened, in plain English
Covidien is recalling its GastriSail gastric positioning devices after reports of gastric or esophageal perforations during bariatric surgery procedures. This recall affects specific model numbers and lot codes used in gastric and bariatric surgeries. Read more at govinfonow.com/recall/72968-covidien-gastrisail-gastric-positioning-device-recall-risk-of-perforation.
Source Summary by GovInfoNow · govinfonow.com/recall/72968-covidien-gastrisail-gastric-positioning-device-recall-risk-of-perforation · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0640-2018
Cite this page
“Covidien GastriSail Gastric Positioning Device Recall: Risk of Perforation.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72968-covidien-gastrisail-gastric-positioning-device-recall-risk-of-perforation. Based on FDA recall #Z-0640-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0640-2018%22&limit=1).
Why it’s dangerous
The device has been reported to cause perforations in the stomach or esophagus during surgical procedures. This can lead to serious complications like internal bleeding or infection if the device is not properly positioned or removed.
Who’s affected
Patients undergoing gastric or bariatric surgery who have received the GastriSail device with the listed model numbers and lot codes are affected. Surgeons and medical staff using the device in procedures are at risk.
How to tell if you have this one
Check if your device has model numbers GPS36 (pediatric) or GPS40 (adult) and lot codes starting with E6J, E6K, E6L, E6M, E7A, E7B, E7C, or E7D followed by numbers and X.
- Brand
Covidien- Category
Medical device
What to do — step by step
Check Device Model
Identify if your device is GPS36 (pediatric) or GPS40 (adult) with the specified lot codes.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0640-2018 (September 21, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0640-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.