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 staplers that may be missing a critical sled component. This can lead to failure in forming staple lines when dividing tissue, potentially causing bleeding or leakage.
The sled component is essential for deploying staples correctly. If missing, the staplers cannot form proper staple lines when dividing tissue, which may result in 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 specific staplers may experience complications.
Check for the model numbers 0214364763, 0214456590, 0214435328, 0214983139, 0215042012, 0215234651, or 0215288296 on the packaging or product labels. These specific lots were affected by the missing sled component issue.
Inspect the stapler for the presence of the sled component. If missing, stop using the device immediately.
The staplers may be missing a sled component, which is necessary for proper staple deployment. This can cause failure to form staple lines when dividing tissue, leading to bleeding or leakage.
Lots 0214364763, 0214456590, 0214435328, 0214983139, 0215042012, 0215234651, and 0215288296 are affected.
Check the lot number on the packaging or product label. If it matches the affected lots listed, the stapler is part of the recall.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1832-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1832-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
