Medtronic recalls Endo GIA Universal and XL staplers (model KIT-DE-0080) due to potential missing sled component causing staple deployment failure, which may lead to 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 XL staplers (model KIT-DE-0080) because a critical sled component might be missing. This could cause staple deployment to fail when dividing tissue, potentially leading to bleeding or leakage.
The sled component is essential for proper staple deployment. If missing, the stapler may fail to form a staple line when dividing tissue, causing bleeding or leakage of bodily fluids.
Surgical professionals using Medtronic Endo GIA Universal or XL staplers with model KIT-DE-0080 are affected. Those performing tissue division procedures are at the highest risk.
Check for the model number KIT-DE-0080 on the Endo GIA Universal or XL stapler. The affected units were sold with specific lot numbers: 0214049646, 0214370002, 0214470664, 0215208426.
Inspect the stapler for a missing sled component, which is critical for staple deployment.
The recalled model is KIT-DE-0080 for Endo GIA Universal and XL staplers.
Missing sled component may cause staple deployment failure, leading to bleeding or leakage of luminal contents.
Affected lot numbers are 0214049646, 0214370002, 0214470664, and 0215208426.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1837-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1837-2018 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.
