Medtronic recalls Tri-Staple 2.0 Curved Tip Intelligent Reload for Signia stapling system. Missing sled component may cause staple line 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 Curved Tip Intelligent Reload staples for Signia stapling systems. The device may have a missing sled component that can cause staple deployment failure, potentially leading to bleeding or leakage.
The sled component is critical for proper staple deployment. If missing, the device may fail to form a staple line when dividing tissue, which can cause bleeding or leakage of bodily fluids.
Surgical professionals using the Signia stapling system with this specific staple product are most at risk. Patients undergoing procedures with this device could experience bleeding or leakage.
Check for the item code SIG45ACTAVM or N7L1049X/N7M0723X on the product packaging. This product was sold with the Signia stapling system 45 mm Vascular/Medium.
Inspect the product for a missing sled component that could cause staple deployment failure.
The recalled staple is Tri-Staple 2.0 Curved Tip Intelligent Reload for Signia stapling system 45 mm Vascular/Medium, with item codes SIG45ACTAVM, N7L1049X, and N7M0723X.
The recall states that failure to form a staple line could lead to bleeding or leakage of luminal contents, but does not specify a risk of serious injury in normal use.
Look for the item codes SIG45ACTAVM, N7L1049X, or N7M0723X on the packaging, or check if it was sold with the Signia stapling system 45 mm Vascular/Medium.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2515-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2515-2018 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.
