Medtronic recalls Endo GIA 45mm Articulating Medium/Thick Reload with Tri-Staple Technology due to potential missing sled component causing staple deployment failure, leading 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 45mm Articulating Medium/Thick Reload surgical devices because they may be missing a critical sled component. This could cause staple lines to fail during tissue division, resulting in bleeding or leakage of bodily fluids.
The device may be missing a sled component that is essential for proper staple deployment. Without this component, the device might fail to form a staple line when dividing tissue, which can lead to bleeding or leakage of bodily fluids.
Surgical professionals using the Endo GIA 45mm Articulating Medium/Thick Reload devices are most at risk. Patients undergoing procedures with these devices may experience complications if the staple line fails.
Check for the item code EGIA45AMT on the device packaging or label. The specific model numbers listed in the recall include N7L0521KX, N7M0047KX, and other variants.
Inspect the device for the presence of the sled component that ensures proper staple deployment.
The recalled device has item code EGIA45AMT with specific model numbers including N7L0521KX, N7M0047KX, and others listed in the recall notice.
The device may be missing a critical sled component that is necessary for staple deployment, which could lead to failure in forming staple lines during tissue division, causing bleeding or leakage.
The recall notice does not specify a fix or remedy; users are advised to check for the missing sled component.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2503-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2503-2018 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.
