Medtronic recalls Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick. Missing sled component may cause staple deployment failure, 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 Intelligent Reload devices for use with Signia stapling systems. The recall is due to a potential missing sled component that could cause staple deployment failure, resulting in bleeding or leakage.
The device may be missing a critical sled component that is necessary for staple deployment. Without this component, the device might fail to form a staple line when tissue is divided, potentially causing bleeding or leakage of luminal contents.
Patients using the Tri-Staple 2.0 Intelligent Reload with Signia stapling system 30 mm Medium/Thick are affected. Those undergoing surgical procedures involving tissue division are at higher risk.
Check for the item code SIG30AMT on the device. The product was sold with model numbers N7L0915X and N7M0468X.
Inspect the device for a missing sled component that could affect staple deployment.
The item code is SIG30AMT.
Failure to form a staple line when tissue is divided could lead to bleeding or leakage of luminal contents.
Look for the item code SIG30AMT or model numbers N7L0915X and N7M0468X.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2513-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2513-2018 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.
