Medtronic recalls Endo GIA 45mm Articulating Vascular Staple Units with Tri-Staple Technology due to potential missing sled component causing staple failure and 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 Vascular Staple Units with Tri-Staple Technology because a critical sled component may be missing, which could lead to staple failure during tissue division and cause bleeding or leakage. This is a serious risk for surgical procedures involving vascular tissue.
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 could lead to bleeding or leakage of bodily fluids during surgery.
Surgical teams and medical professionals using the Endo GIA 45mm Articulating Vascular Staple Units with Tri-Staple Technology are most at risk. Patients undergoing procedures requiring these units could experience bleeding or leakage if the device fails.
Check for the item code EGIA454AVM on the device. The units were sold with model numbers N7L0551KX and N7M0877KX. This recall applies to specific surgical devices used in vascular procedures.
Inspect the device for a missing sled component, which is critical for staple deployment.
The recall indicates the device may be missing a critical sled component, which could lead to staple failure and bleeding or leakage. Do not use until confirmed safe.
Check for the item code EGIA454AVM and model numbers N7L0551KX or N7M0877KX. If you have the device, contact Medtronic for guidance on next steps.
Do not use the device until you confirm it has the correct sled component. The recall does not specify a fix or replacement process.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2511-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2511-2018 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.
