Medtronic recalls Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology (Item Code EGIA45AXT) due to potential missing sled component causing staple line failure and bleeding.
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 45 mm Extra Thick Black Articulating Reload surgical devices because they may be missing a critical sled component. This could lead to failure in forming staple lines during surgery, causing bleeding or leakage of bodily fluids.
The sled component is essential for proper staple deployment. If missing, the device cannot form a staple line when dividing tissue, which may cause bleeding or leakage of bodily fluids during surgery.
Surgical professionals using the Endo GIA 45 mm devices for procedures involving tissue division are most at risk. Patients undergoing surgery with these devices may experience complications.
Check for the item code EGIA45AXT on the device packaging or label. The product was sold with specific serial numbers: N8A0146KX, N8A0327KX, and N8A0907KX.
Inspect the device for a missing sled component that is critical for staple deployment.
The device may be missing a sled component, which is necessary for staple deployment. This could lead to failure in forming staple lines during surgery, causing bleeding or leakage of bodily fluids.
Check the device for a missing sled component. If you find it missing, stop using the device immediately and contact Medtronic for further instructions.
The item code is EGIA45AXT. The product was sold with specific serial numbers: N8A0146KX, N8A0327KX, and N8A0907KX.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2510-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2510-2018 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.
