Medtronic Endo GIA Stapler Recall Due to Missing Sled Component
Medtronic is recalling Endo GIA staplers that may be missing a sled component, which could cause staple line failure, bleeding, or leakage during surgery.
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 medical device.
Plain-English summary
Medtronic is recalling the Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology (Item Code EGIA454AVM). The recall involves specific units identified by codes N7L0551KX and N7M0877KX. These devices were distributed nationwide in the United States and internationally to numerous countries, including Albania, Algeria, Austria, Belgium, and the United Kingdom.
The recall was initiated because the device may be missing a sled component. This component is responsible for staple deployment. If the sled 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 a surgical procedure.
Healthcare providers and facilities that have received these devices should stop using them and contact Medtronic for instructions on how to return or replace the affected units. Patients who have had surgery using these devices should contact their healthcare provider if they have concerns about their surgical outcome.
The recalled product
- Product
- Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA454AVM
- 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)
- N7L0551KX & N7M0877KX
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 Vascular Reloads Recalled for Missing Sled Component
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- SevereMedtronic Endo GIA Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
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