Medtronic recalls Endo GIA universal staplers with specific lot numbers due to potential missing sled component causing staple deployment failure and bleeding or leakage risks.
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 with certain lot numbers because they may be missing a critical sled component. This could lead to staple deployment failure when dividing tissue, potentially causing bleeding or leakage of bodily fluids.
The sled component is essential for properly deploying staples when dividing tissue. If this component is missing, the stapler may fail to form a staple line, which can result in bleeding or leakage of bodily fluids from the surgical site.
Patients using Endo GIA universal or universal XL staplers for surgical procedures are affected. Surgeons and medical staff who use these devices during procedures are at the highest risk.
Check your Endo GIA universal or universal XL stapler's lot numbers: 0214463634, 0215280952 for model KITDE0143, and 0214013887, 0214144177, 0214260194, 0214470767, 0214956044, 0214620382, 0214744957, 0215079103, 0215151206 for model KITDE0154.
Identify your Endo GIA universal or universal XL stapler's lot numbers from the list provided in the recall notice.
Reach out to Medtronic directly to confirm if your specific lot number is affected and to get instructions on next steps.
The staplers may be missing a critical sled component needed for staple deployment, which could cause failure to form a staple line when dividing tissue, leading to bleeding or leakage of bodily fluids.
Lot numbers 0214463634, 0215280952 for model KITDE0143, and 0214013887, 0214144177, 0214260194, 0214470767, 0214956044, 0214620382, 0214744957, 0215079103, 0215151206 for model KITDE0154.
No, but you should check your lot numbers and contact Medtronic to determine if your specific model is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1840-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1840-2018 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.
