Medtronic recalls Endo GIA universal and universal XL staplers (Item Code KIT1095V) that may have a missing sled component, risking bleeding or leakage during tissue division. Affected units were sold with Lot 0214062622.
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. Affected units have Item Code KIT1095V and Lot 0214062622.
The sled component is critical for staple deployment. If missing, the staplers may fail to form a staple line when dividing tissue, causing bleeding or leakage of luminal contents.
Surgical professionals using Medtronic Endo GIA staplers for tissue division are most at risk. Affected units have Item Code KIT1095V and Lot 0214062622.
Check for Item Code KIT1095V on the box or packaging. Affected units were sold with Lot 0214062622.
Inspect the stapler for a missing sled component, which is critical for staple deployment.
Endo GIA universal and Endo GIA universal XL staplers (Item Code KIT1095V).
Failure to form a staple line when dividing tissue, leading to bleeding or leakage of luminal contents.
Check for Item Code KIT1095V on the box or packaging. Affected units were sold with Lot 0214062622.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1825-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1825-2018 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.
