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 were sold in specific lots.
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 might be missing a critical sled component. This could cause bleeding or leakage when dividing tissue during surgery, making it important to check your device.
The sled component is essential 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 staff using Medtronic Endo GIA universal or universal XL staplers in hospitals or clinics are most at risk. Patients undergoing procedures with these devices could experience bleeding or leakage if the stapler malfunctions.
Check for the lot numbers 0215122341 or 0215226207 on the packaging. These staplers were sold in specific sizes (30 mm, 45 mm, 60 mm) with 2.0 mm, 2.5 mm, 3.5 mm, or 4.8 mm loading units.
Inspect the stapler for a missing sled component, which is critical for staple deployment.
The recall is due to a potential missing sled component that could cause failure to form a staple line when dividing tissue, leading to bleeding or leakage.
Check for the lot numbers 0215122341 or 0215226207 and inspect for a missing sled component. If found, contact Medtronic for guidance.
Yes, using a stapler with a missing sled component may cause bleeding or leakage of luminal contents during tissue division.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1865-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1865-2018 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.
