Medtronic recalls Endo GIA universal and universal XL staplers that may have a missing sled component, causing failure to form staple lines during tissue division and potential bleeding or leakage.
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 have a missing sled component. This could lead to failure in forming staple lines when dividing tissue, resulting in bleeding or leakage of luminal contents.
The sled component is critical for staple deployment. If missing, the staplers may fail to form a staple line when dividing tissue, causing bleeding or leakage of luminal contents.
Endo GIA universal and universal XL staplers used in surgical procedures by medical professionals. Surgeons and surgical teams are most at risk during tissue division operations.
The recalled staplers have model numbers from the lots listed: 0214874566, 0215001737, 0215151361. They were sold with specific staple sizes (2.0 mm, 2.5 mm, 3.5 mm, 4.8 mm) and lengths (30 mm, 45 mm, 60 mm).
Inspect the stapler for a missing sled component, which is critical for staple deployment.
The staplers may have a missing sled component, which can cause failure to form a staple line when dividing tissue, leading to bleeding or leakage of luminal contents.
Check the lot numbers: 0214874566, 0215001737, 0215151361. The affected staplers use specific staple sizes (2.0 mm, 2.5 mm, 3.5 mm, 4.8 mm) and lengths (30 mm, 45 mm, 60 mm).
Inspect the stapler for a missing sled component. If found, contact Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1863-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1863-2018 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.
