Medtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component
Medtronic is recalling specific Endo GIA 45mm Vascular Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that can lead to significant injury, specifically bleeding or leakage of luminal contents.
Plain-English summary
Medtronic is recalling specific Endo GIA 45mm Gray Articulating Vascular Reloads with Tri-Staple Technology (Item Code EGIA45AV) due to a manufacturing defect. The affected devices may be missing a sled component, which is responsible for deploying the staples.
If the sled component is missing, the device may fail to form a staple line when tissue is divided during a procedure. This failure could lead to bleeding or the leakage of luminal contents. The recall covers units distributed nationwide in the United States and internationally to numerous countries, including those in Europe, the Middle East, Africa, and Asia.
Healthcare providers and facilities should check their inventory for the specific lot codes N7L0823KX, N8A0799KX, and N8B1008KX. Affected units should be removed from use and returned to Medtronic according to the company's instructions.
The recalled product
- Product
- Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item Code EGIA45AV
- Manufacturer
- COVIDIEN MEDTRONIC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- N7L0823KX
- N8A0799KX & N8B1008KX
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by COVIDIEN MEDTRONIC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same manufacturer · COVIDIEN MEDTRONIC
See all →- SevereEndo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
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- SevereMedtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
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- SevereMedtronic Endo GIA Stapler Recall Due to Missing Sled Component
FDA (Devices) · 2018-07-25
- SevereMedtronic Endo GIA Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
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