Medtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
Medtronic is recalling Tri-Staple 2.0 Black Intelligent Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury (bleeding or leakage) has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medtronic is recalling the Tri-Staple 2.0 Black Intelligent Reload for use with the Signia stapling system, 60 mm Extra Thick (Item Code SIG60AXT). 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. The affected products were distributed nationwide in the U.S. and internationally to numerous countries, including Albania, Algeria, Austria, and the United Kingdom.
Healthcare providers should stop using the affected devices and contact Medtronic for further instructions. The specific lot codes associated with this recall are N7L0852X, N7M0130X, N8A0145X, N8A0336X, N7L0931X, N7M0639X, N8A0796X, and N8B0993X.
The recalled product
- Product
- Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT
- 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 (7)
- N7L0852X
- N7M0130X
- N8A0145X
- N8A0336X
- N7L0931X
- N7M0639X
- N8A0796X & N8B0993X
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
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See all →- SevereMedtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component
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- 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
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- SevereEndo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
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