Medtronic recalls Endo GIA universal staplers that may have a missing sled component, risking bleeding or leakage during tissue division. Affected units include specific lot numbers and model types.
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 staplers that may have a missing sled component. This could cause failure to form a staple line when dividing tissue, leading to bleeding or leakage. Affected units include specific model types and lot numbers.
The sled component is critical for deploying staples properly. If missing, the device cannot form a staple line when dividing tissue, which may cause bleeding or leakage of bodily fluids.
Surgical professionals using Medtronic Endo GIA staplers for tissue division procedures are most at risk. Patients undergoing surgery with these devices may experience bleeding or leakage if the device fails.
Check for the model names: Endo GIA universal or Endo GIA universal XL staplers. Look for specific lot numbers listed in the recall notice, such as 0215082707 or 0215120700.
Identify if your stapler is an Endo GIA universal or Endo GIA universal XL model.
Compare your lot number to the listed numbers in the recall notice.
The device may be missing a sled component, which is responsible for staple deployment. This can cause failure to form a staple line when dividing tissue, leading to bleeding or leakage.
Endo GIA universal and Endo GIA universal XL staplers with specific lot numbers listed in the recall notice.
Check the model name and compare the lot number to the numbers provided 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-1847-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1847-2018 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.
