Medtronic recalls Endo GIA 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple Technology (Item EGIA30CTAV) due to risk of staple deployment failure causing bleeding or leakage. Affected units have lot numbers N7G0756KX or N7L0819KX.
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 30mm vascular staplers that may have a missing sled component, which can cause staple deployment failure during tissue division. This could lead to bleeding or leakage of bodily fluids if the device is used improperly.
The sled component is critical for proper staple deployment. If missing, the device may fail to form a staple line when dividing tissue, potentially causing bleeding or leakage of bodily fluids during surgery.
Surgical professionals using the Endo GIA 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple Technology (Item Code EGIA30CTAV) are most at risk. Affected units have specific lot numbers: N7G0756KX and N7L0819KX.
Check for the product name 'Endo GIA 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple Technology' and item code EGIA30CTAV. Affected units have lot numbers N7G0756KX or N7L0819KX.
Identify the lot number on the device, which should be either N7G0756KX or N7L0819KX for affected units.
Reach out to Medtronic directly to confirm if your device is affected and to get instructions for next steps.
The device may be missing a critical sled component needed for staple deployment, which could lead to failure in forming staple lines during tissue division, causing bleeding or leakage.
Check the lot number on your device; if it's N7G0756KX or N7L0819KX, contact Medtronic for further instructions.
Yes, if the device fails to form a staple line during tissue division, it could cause bleeding or leakage of bodily fluids.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1821-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1821-2018 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.