Medtronic recalls Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium. Missing sled component may cause 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 Intelligent Reload devices for use with Signia stapling systems. The recall is due to a potential missing sled component that could cause failure to form staple lines, 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 dividing tissue, which could cause bleeding or leakage of bodily fluids.
Patients using the Tri-Staple 2.0 Intelligent Reload with Signia stapling system 30 mm Vascular/Medium are affected. Surgeons and medical staff performing procedures with this device are at highest risk.
Check for the item code SIG30AVM on the device. The product was sold with model numbers N7L1019X, N7M0129X, and N7L0734X.
Inspect the device for a missing sled component that is necessary for staple deployment.
The device may be missing a critical sled component, which could cause failure to form staple lines and lead to bleeding or leakage. It is not safe to use without verification.
The official recall does not specify a remedy, so contact Medtronic directly for guidance.
Look for the item code SIG30AVM or model numbers N7L1019X, N7M0129X, or N7L0734X on the device.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2508-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2508-2018 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.