Medtronic recalls Endo GIA universal and universal XL staplers that may have a missing sled component, risking bleeding or leakage during tissue division. Affected units include specific lot numbers from 2015.
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 Endo GIA universal and universal XL staplers that may have a missing sled component. This could cause failure to form staple lines when dividing tissue, leading to bleeding or leakage.
The sled component is critical for deploying staples correctly. If missing, the stapler may fail to form a staple line when dividing tissue, causing bleeding or leakage of bodily fluids.
Surgical professionals using the Endo GIA universal or universal XL staplers during procedures are most at risk. Patients undergoing surgery with these devices may experience bleeding or leakage if the stapler malfunctions.
Check for lot numbers 0215050309, 0215108007, 0215050310, 0215050308, 0215050311, 0215050312, 0215050313, 0215037144, 0215037143, or 0215108008 on the packaging or device label.
Inspect the stapler for a missing sled component, which is essential for proper staple deployment.
The stapler may have a missing sled component, which can cause failure to form staple lines when dividing tissue, leading to bleeding or leakage.
Affected lot numbers are 0215050309, 0215108007, 0215050310, 0215050308, 0215050311, 0215050312, 0215050313, 0215037144, 0215037143, and 0215108008.
The recall does not require immediate discontinuation; however, you should check for a missing sled component before use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1854-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1854-2018 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.
