Medtronic recalls Endo GIA universal staplers with specific lot numbers due to potential missing sled component that may cause failure to form staple lines, leading to 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 Endo GIA universal XL staplers with certain lot numbers because they may be missing a critical sled component. This could cause staple lines to fail when dividing tissue, potentially resulting in bleeding or leakage of bodily fluids.
The sled component is essential for deploying staples correctly. If missing, the stapler may fail to form a proper staple line when dividing tissue, which can lead to bleeding or leakage of bodily fluids.
Patients and medical professionals using the Endo GIA staplers with the listed lot numbers are affected. Those performing surgical procedures involving tissue division are at the highest risk.
Check the item number on the product box: PST04089 for the sleeve model and PST04090 for the bypass model. The affected products have specific lot numbers listed in the recall notice.
Review the lot numbers on the product box to determine if your Endo GIA stapler is affected. Affected lot numbers are listed in the recall notice.
The recall involves Endo GIA universal and Endo GIA universal XL staplers with item numbers PST04089 and PST04090.
If the sled component is missing, the stapler may fail to form a staple line when dividing tissue, potentially causing bleeding or leakage of bodily fluids.
Check the lot numbers on the product box. Affected lot numbers are 0215237526, 0214991351, 0214991350, 0215157998, 0215157997 for the sleeve model and 0215237527, 0215282382, 0214991349, 0214991348, 0214991347 for the bypass model.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1855-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1855-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
