Medtronic recalls Endo GIA universal and universal XL staplers that may be missing a 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 surgical 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. Affected units were sold in specific lots.
The sled component ensures proper staple deployment. If missing, the staplers may fail to form a staple line when dividing tissue, which can cause bleeding or leakage of bodily fluids.
Surgical professionals using Medtronic Endo GIA staplers for tissue division procedures are most at risk. Patients undergoing surgery with these devices may experience bleeding or leakage if the sled component is missing.
Check for the lot number 0215122344 on the packaging. The affected staplers are Endo GIA universal and universal XL models with specific staple sizes (2.0 mm, 2.5 mm, 3.5 mm, or 4.8 mm).
Inspect the stapler for a missing sled component that could cause failure to form staple lines during tissue division.
The staplers may be missing a sled component, which is critical for staple deployment. This can lead to failure in forming staple lines when dividing tissue, potentially causing bleeding or leakage.
Check for the lot number 0215122344 on the packaging. Affected models are Endo GIA universal and universal XL with specific staple sizes (2.0 mm, 2.5 mm, 3.5 mm, or 4.8 mm).
The recall does not specify a remedy for missing sled components. Contact Medtronic directly for guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1866-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1866-2018 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.
