Medtronic recalls two models of Endo GIA staplers (HEMIGX1 ZESTAW DO HEMICOLECTOMII and LAPPH ZASTAW DO PRAWEJ) due to a missing sled component that can cause bleeding or leakage during tissue division.
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 two models of surgical staplers because a critical component may be missing, which could lead to bleeding or leakage during tissue division. This hazard affects patients undergoing surgery where these staplers are used.
The stapler may be missing a sled component that is essential for proper staple deployment. Without this component, the stapler might fail to form a staple line when dividing tissue, potentially causing bleeding or leakage of internal fluids.
Patients using these staplers for surgery are most at risk, particularly those undergoing procedures involving tissue division. The affected products were sold with specific lot numbers.
Check for the product names 'HEMIGX1 ZESTAW DO HEMICOLECTOMII' or 'LAPPH ZASTAW DO PRAWEJ' with lot numbers 0214909888, 0214916144 or 0215015272, 0215298205.
Identify the lot numbers from the product labels to confirm if your stapler is affected.
Reach out to Medtronic directly for specific instructions on how to proceed with the recall.
The stapler may be missing a critical sled component that is necessary for staple deployment, which could lead to bleeding or leakage of internal fluids during tissue division.
Lot numbers 0214909888, 0214916144 for the first model and 0215015272, 0215298205 for the second model.
No, but you should check the lot numbers and contact Medtronic for further instructions as the remedy is not specified in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1830-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1830-2018 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.
