Medtronic recalls Tri-Staple 2.0 Curved Tip Intelligent Reload for possible staple deployment failure causing bleeding or leakage during surgery. Affected units have specific item codes.
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 Tri-Staple 2.0 Curved Tip Intelligent Reload surgical staples because a missing sled component may cause staple deployment failure. This could lead to bleeding or leakage of bodily fluids during surgery.
The device may be missing a critical sled component that guides staple deployment. Without this part, the staples might not form properly when dividing tissue, potentially causing bleeding or leakage of bodily fluids.
Surgical patients and medical professionals using the Tri-Staple 2.0 Curved Tip Intelligent Reload with Signia stapling system. Those with the specific item codes N7G0756KX or N7L0819KX are most at risk.
Check for item codes N7G0756KX or N7L0819KX on the product. The product is part of the Signia stapling system and was sold with specific item codes.
Look for item codes N7G0756KX or N7L0819KX on the Tri-Staple 2.0 Curved Tip Intelligent Reload device.
The device may be missing a sled component that is necessary for staple deployment, which could lead to failure to form a staple line when tissue is divided, causing bleeding or leakage of luminal contents.
Check for item codes N7G0756KX or N7L0819KX on the Tri-Staple 2.0 Curved Tip Intelligent Reload device.
The recall record does not specify a remedy, so contact Medtronic directly for guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2516-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2516-2018 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.