Medtronic recalls Endo GIA Universal and XL staplers that may have a missing sled component, risking failure to form staple lines and causing bleeding or leakage during gastric bypass procedures.
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 be missing a critical sled component. This could lead to failure in forming staple lines during gastric bypass surgery, potentially causing bleeding or leakage of internal tissues.
The staplers may lack a sled component necessary for proper staple deployment. Without this part, the device might fail to create a secure staple line when dividing tissue, which could cause bleeding or leakage of internal contents.
Patients who have undergone gastric bypass surgery using these specific staplers are most at risk. The recall applies to devices sold with certain lot numbers.
Check for the lot numbers 0215124172 or 0215253056 on the device packaging. These staplers are used in gastric bypass procedures and come with specific loading units.
Look for the lot numbers 0215124172 or 0215253056 on the packaging or device itself.
The staplers may be missing a sled component that is essential for forming staple lines. This can lead to failure in dividing tissue, causing bleeding or leakage of internal contents.
Check the lot number on the packaging or device; affected units have lot numbers 0215124172 or 0215253056.
The recall does not specify an immediate stop-use requirement; however, you should check the lot number and contact Medtronic if you have the affected model.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1848-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1848-2018 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.
