Medtronic Tri-Staple 2.0 Curved Tip Reloads Recalled for Missing Sled Component
Medtronic is recalling Tri-Staple 2.0 Curved Tip Intelligent 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 source text describes a device defect that may lead to bleeding or leakage of luminal contents, which constitutes a significant injury risk. This aligns with the rubric criterion for 'Severe' (score 4) involving significant injury reports or high-risk medical device defects.
Plain-English summary
Medtronic is recalling Tri-Staple 2.0 Curved Tip Intelligent Reloads (Item Code EGIA30CTAV) used with the Signia stapling system. 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 agency has classified this as a Class II recall.
The affected products were distributed nationwide in the U.S. and internationally to numerous countries, including Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, 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, Netherlands, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, and the United Kingdom. The specific lot codes involved are N7G0756KX and N7L0819KX.
The recalled product
- Product
- Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV
- 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)
- N7G0756KX & N7L0819KX
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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- SevereMedtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
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