Medtronic recalls Endo GIA 60mm 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 60mm Articulating Vascular/Medium Loading Units with Tri-Staple Technology because a critical sled component may be missing, which could lead to staple failure during surgery and cause bleeding or leakage of tissue contents.
The device may be missing a sled component that is essential for staple deployment. Without this component, the device might fail to form a staple line when dividing tissue, which could cause bleeding or leakage of bodily fluids during surgery.
Surgical teams using the Endo GIA 60mm Articulating Vascular/Medium Loading Units with Tri-Staple Technology are most at risk. This recall affects medical professionals and hospitals that use the specific item codes listed.
Check for the item codes: N7M0045KX, N7M0398KX, N8A0523KX, N8B0088KX, N7M0070KX, N8A0255KX, and N8B0080KX. These units were sold with the specific model name and size.
Inspect the device for a missing sled component that is critical for staple deployment.
The device may be missing a sled component that is responsible for staple deployment, which could lead to failure in forming a staple line during surgery, causing bleeding or leakage of tissue contents.
The affected item codes are N7M0045KX, N7M0398KX, N8A0523KX, N8B0088KX, N7M0070KX, N8A0255KX, and N8B0080KX.
Check the item code on the device; the affected codes are listed in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2506-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2506-2018 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.
