Medtronic recalls Endo GIA Universal Articulating Loading Units 30mm-2.5mm (Item 030451) due to potential missing sled component causing staple deployment failure, which may lead to 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 Articulating Loading Units 30mm-2.5mm (Item Code 030451) because the device may be missing a critical sled component that can cause staple deployment failure during surgery. This could result in bleeding or leakage of internal tissues if the device is used without the proper component.
The device may be missing a sled component that is essential for properly deploying staples. Without this component, the device might fail to form a staple line when dividing tissue, potentially causing bleeding or leakage of internal fluids.
Surgical professionals using the Endo GIA Universal Articulating Loading Units 30mm-2.5mm (Item Code 030451) are most at risk, particularly those who have purchased units from specific lots listed in the recall notice.
Check if your Endo GIA Universal Articulating Loading Unit is labeled with Item Code 030451 and belongs to the specific lots listed: N7L0071KX, N7L0527KX, N7L0792KX, N7L0914KX, N7L1014KX, N7L1159KX, N8A0154KX, N8A0553KX, N8A0850KX, N8C0830KX, N8C0847KRX, N8C0848KRX.
Identify the lot number on your Endo GIA Universal Articulating Loading Unit to determine if it is in the recalled list of lots.
Reach out to Medtronic directly to confirm if your unit is affected and to receive instructions on next steps.
The device may be missing a critical sled component that is necessary for staple deployment, which could lead to failure in forming a staple line during tissue division, potentially causing bleeding or leakage.
Check the lot number on your unit to see if it matches the recalled lots. If it does, contact Medtronic for further instructions.
The recall states that failure to form a staple line could lead to bleeding or leakage of luminal contents, but the remedy does not specify immediate action to stop use, so the risk is not immediately life-threatening.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1815-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1815-2018 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.
