Medtronic recalls Endo GIA Universal Articulating Loading Units 30mm-3.5mm (Item 030452) due to potential missing sled component causing staple deployment failure, which may lead to 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 Endo GIA Universal Articulating Loading Units 30mm-3.5mm (Item Code 030452) because a missing sled component may cause staple deployment failure during tissue division, potentially leading to bleeding or leakage.
The sled component is critical for staple deployment. If missing, the device may fail to form a staple line when dividing tissue, which can cause bleeding or leakage of bodily fluids.
Surgical professionals using the Endo GIA universal staplers with the recalled loading units (30mm-3.5mm) are most at risk during procedures involving tissue division. Patients undergoing surgery with these devices could experience bleeding or leakage.
Check for the Endo GIA Universal Articulating Loading Unit 30mm-3.5mm (Item Code 030452) with lot numbers N7L0191KX, N7M0944KX, N8B0234KX, or N8C0147KX. These units were sold with GTIN #1 10884523002836 and GTIN #2 20884523002833.
Inspect the unit for a missing sled component, which is essential for staple deployment during tissue division.
The recalled device is the Endo GIA Universal Articulating Loading Unit 30mm-3.5mm (Item Code 030452).
If the sled component is missing, the device may fail to form a staple line when dividing tissue, leading to bleeding or leakage of luminal contents.
Lot numbers N7L0191KX, N7M0944KX, N8B0234KX, and N8C0147KX are affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1816-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1816-2018 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.
