Medtronic Tri-Staple 2.0 Intelligent Reloads Recalled for Missing Sled Component
Medtronic is recalling Tri-Staple 2.0 Intelligent Reloads because a missing sled component may prevent staple formation, leading to 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 source describes a structural defect in a medical device that can lead to bleeding or leakage of luminal contents, which constitutes a significant injury risk under the rubric for Severe recalls.
Plain-English summary
Medtronic is recalling specific Tri-Staple 2.0 Intelligent Reloads for use with the Signia stapling system (30 mm Vascular/Medium, Item Code SIG30AVM). The recall affects units with lot codes N7L1019X, N7M0129X, and N7L0734X. These devices were distributed nationwide in the U.S. and internationally to numerous countries including Albania, Algeria, Austria, and the United Kingdom.
The recall was initiated because the devices 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 can lead to bleeding or leakage of luminal contents during surgical procedures.
Healthcare providers and facilities should check their inventory for the affected lot codes and stop using these specific reloads. Patients who have had procedures using these devices should contact their healthcare provider if they experience complications such as bleeding or leakage.
The recalled product
- Product
- Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30AVM
- 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)
- N7L1019X
- N7M0129X & N7L0734X
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
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- SevereEndo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
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