Medtronic recalls Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick due to potential missing sled component causing failure to form staple lines, leading to 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 Tri-Staple 2.0 Black Intelligent Reload surgical staples because a missing sled component may cause failure to form staple lines during tissue division, potentially leading to bleeding or leakage. This recall affects specific model numbers sold with the Signia stapling system.
The device may be missing a sled component that is essential for proper staple deployment. Without this component, the system might fail to form a staple line when dividing tissue, which could cause bleeding or leakage of bodily fluids.
Surgical patients and healthcare providers using the Tri-Staple 2.0 Black Intelligent Reload with Signia stapling system 60 mm Extra Thick. Those most at risk are patients undergoing procedures where staple line integrity is critical.
Check for the item code SIG60AXT on the product label. The affected models include N7L0852X, N7M0130X, N8A0145X, N8A0336X, N7L0931X, N7M0639X, N8A0796X, and N8B0993X. These were sold with the Signia stapling system 60 mm Extra Thick.
Look for the item code on the product label to confirm if it matches the affected models listed.
The device may be missing a sled component that is responsible for staple deployment, which could lead to failure in forming staple lines during tissue division, potentially causing bleeding or leakage.
The affected models include N7L0852X, N7M0130X, N8A0145X, N8A0336X, N7L0931X, N7M0639X, N8A0796X, and N8B0993X.
Check the product label for the item code SIG60AXT. The affected models are listed above and were sold with the Signia stapling system 60 mm Extra Thick.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2507-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2507-2018 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.
