Medtronic Recalls Tri-Staple 2.0 Curved Tip Intelligent Reloads
Medtronic is recalling specific Tri-Staple 2.0 Curved Tip Intelligent Reloads because a missing sled component may prevent staple formation, potentially 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 recall is classified as FDA Class II and involves a structural defect that may lead to significant injury, specifically bleeding or leakage of luminal contents, which aligns with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Medtronic is recalling specific units of the Tri-Staple 2.0 Curved Tip Intelligent Reload for use with the Signia stapling system 30 mm Vascular/Medium. The affected products are identified by Item Code SIG30ACTAVM and lot codes N7L1163X and N7M0156X. The recall is classified as Class II by the FDA.
The recall is being issued 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.
The affected products were distributed nationwide in the U.S.A. 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 lot codes and contact Medtronic for further instructions.
The recalled product
- Product
- Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30ACTAVM
- 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)
- N7L1163X & N7M0156X
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
FDA (Devices) · 2018-07-25
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