Medtronic recalls Endo GIA universal and XL staplers that may have a missing sled component, causing failure to form staple lines and potential bleeding or leakage during tissue division.
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Medtronic is recalling Endo GIA universal and universal XL staplers that may be missing a critical sled component. This could lead to failure in forming staple lines when dividing tissue, potentially causing bleeding or leakage of luminal contents.
The sled component is essential for deploying staples correctly. If missing, the stapler cannot form a proper staple line when dividing tissue, which may cause bleeding or leakage of bodily fluids.
Surgical professionals using Medtronic Endo GIA universal or universal XL staplers for tissue division procedures are most at risk. Patients undergoing surgery with these devices may experience bleeding or leakage if the stapler fails to form staple lines.
Check for the model number 'Endo GIA universal' or 'Endo GIA universal XL' on the stapler. The recall includes specific lot numbers from the production date listed in the recall notice.
Inspect the stapler for a missing sled component that is necessary for staple deployment.
The Endo GIA universal and Endo GIA universal XL staplers are recalled.
The staplers may be missing a sled component, which is critical for forming staple lines during tissue division, potentially causing bleeding or leakage.
Check for the model number 'Endo GIA universal' or 'Endo GIA universal XL' on the stapler. The recall includes specific lot numbers from the production date listed in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1839-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1839-2018 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.