Medtronic recalls Endo GIA universal and universal XL staplers that may have a missing sled component, risking bleeding or leakage during laparoscopic cystectomy. 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 and universal XL staplers that may be missing a critical sled component. This could cause failure to form staple lines when dividing tissue, leading to bleeding or leakage during surgery.
The sled component ensures proper staple deployment. If missing, the staplers may fail to form a staple line when tissue is divided, causing bleeding or leakage of internal fluids.
Surgical teams using Medtronic Endo GIA staplers for laparoscopic cystectomies are most at risk. Patients undergoing these procedures with affected units may experience bleeding or leakage.
Check for lot numbers 0214090852, 0214522213, 0215009132, or 0215153445 on the product packaging. The product is a laparoscopic cystectomy kit with Endo GIA universal or universal XL staplers.
Inspect the stapler for a missing sled component, which is critical for staple deployment.
The staplers may be missing a sled component, which can cause failure to form staple lines when tissue is divided, leading to bleeding or leakage.
Affected lot numbers are 0214090852, 0214522213, 0215009132, and 0215153445.
The recall does not specify an immediate stop; however, checking for the missing sled component is recommended.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1834-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1834-2018 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.
