Medtronic recalls Endo GIA universal staplers with item number KIT00486R that may have a missing sled component, risking bleeding or leakage during tissue division. Affected units include specific lot numbers.
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 have specific lot numbers.
The sled component is critical for staple deployment. If missing, the device cannot properly form a staple line when dividing tissue, which can cause bleeding or leakage of internal fluids.
Surgical professionals using Medtronic Endo GIA universal 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 the item number KIT00486R on the device. Affected units include lot numbers: 0213984473, 0213583578, 0213596057, 0214068986, and 0213589227.
Inspect the device for a missing sled component, which is critical for staple deployment.
The item number is KIT00486R.
Affected lot numbers are 0213984473, 0213583578, 0213596057, 0214068986, and 0213589227.
Missing sled component may cause failure to form a staple line when dividing tissue, leading to bleeding or leakage of luminal contents.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1831-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1831-2018 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.
