Medtronic recalls Endo GIA universal and universal XL staplers that may have a missing sled component, risking failure to form staple lines during tissue division and potential 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 Endo GIA universal and universal XL staplers that may be missing a critical sled component. This could cause the staplers to fail when dividing tissue, leading to bleeding or leakage. Affected units were sold with specific lot numbers.
The sled component is essential for properly deploying staples when dividing tissue. If missing, the stapler may not form a staple line correctly, causing tissue to bleed or leak luminal contents during surgery.
Surgical professionals using Medtronic Endo GIA staplers for procedures involving tissue division are most at risk. Patients undergoing surgery with these devices may experience bleeding or leakage if the device fails.
Check for lot numbers: 0214930629, 0214993038, 0215068848, 0215124286, 0215124285, 0214793818, 0215130759, 0215243237. The product is labeled as 'BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1)' for Endo GIA universal and universal XL staplers.
Identify the lot number on the device packaging or label to determine if it is affected.
Reach out to Medtronic directly for specific instructions on whether your device is affected and what to do next.
The staplers may be missing a sled component, which is necessary for proper staple deployment. This can cause failure to form a staple line when dividing tissue, leading to bleeding or leakage.
Check the lot number on the device packaging or label. Affected units have specific lot numbers: 0214930629, 0214993038, 0215068848, 0215124286, 0215124285, 0214793818, 0215130759, 0215243237.
The recall does not require immediate discontinuation; however, affected units should be checked for the missing component and contacted for guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1844-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1844-2018 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.
