Medtronic Endo GIA Reloads Recalled for Missing Sled Component
Medtronic is recalling specific Endo GIA 45mm 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 risk of significant injury (bleeding or leakage of luminal contents) due to a structural defect in a surgical device.
Plain-English summary
Medtronic is recalling the Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology (Item Code EGIA45CTAVM). The recall is due to a potential defect where the device may be missing a sled component. This component is responsible for staple deployment.
If the sled component is missing, the device may fail to form a staple line when tissue is divided. This failure could lead to bleeding or the leakage of luminal contents during surgical procedures.
The affected products were distributed nationwide in the U.S. and internationally to numerous countries, including Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta, Martinique, Moldova, Morocco, Namibia, the Netherlands, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, the Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, the United Arab Emirates, and the United Kingdom. Healthcare providers should check their inventory for the specific item code and stop using any affected units.
The recalled product
- Product
- Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology, Item Code EGIA45CTAVM
- 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 (1)
- N7L1041KX & N8A0199KX
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 →- SevereMedtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
- SevereMedtronic Endo GIA Reloads Recalled for Missing Sled Component
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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
- SevereEndo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
FDA (Devices) · 2018-07-25
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