Medtronic recalls Endo GIA Auto Suture Universal Articulating Loading Units 45mm-3.5mm (Item Code 030455) 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 Auto Suture Universal Articulating Loading Units 45mm-3.5mm (Item Code 030455) because the device may be missing a critical sled component that can cause staple deployment failure. This could result in bleeding or leakage of tissue contents during surgical procedures.
The device may be missing a sled component that is essential for deploying staples correctly. Without this component, the device might fail to form a staple line when dividing tissue, potentially causing bleeding or leakage of internal bodily fluids.
Surgical professionals using the Endo GIA universal staplers with the specific loading units (45mm-3.5mm) are affected. Patients undergoing surgery with these devices are at risk of bleeding or leakage if the device fails to properly form staple lines.
Check for the Endo GIA Auto Suture Universal Articulating Loading Unit 45mm-3.5mm (Item Code 030455). The product was sold with specific lot numbers: N7F0576KX, N7L0032KX, N7L0239KX, N7L0519KX, N7M0104KX, N7M0383KX, N7M0584KX, N7M0696KX, N8A0032KX, N8A0324KX, N8A0477KRX, N8A0551KX, N8C0357KX.
Inspect the device for a missing sled component that is necessary for staple deployment.
The recalled device is the Endo GIA Auto Suture Universal Articulating Loading Unit 45mm-3.5mm (Item Code 030455).
If the sled component is missing, the device may fail to form a staple line when dividing tissue, leading to bleeding or leakage of luminal contents.
Check for the specific lot numbers: N7F0576KX, N7L0032KX, N7L0239KX, N7L0519KX, N7M0104KX, N7M0383KX, N7M0584KX, N7M0696KX, N8A0032KX, N8A0324KX, N8A0477KRX, N8A0551KX, N8C0357KX.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1818-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1818-2018 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.
