Tri-Staple 2.0 Surgical Stapler Reloads Recalled for Malfunction Risk
Covidien is recalling certain Tri-Staple 2.0 surgical stapler reloads due to a mechanical defect that may cause the device to malfunction during surgery. Affected units may fail to form staples properly, potentially causing serious surgical complications.
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: This is an FDA Class II recall involving a risk-of-harm medical device with serious potential consequences including death, sepsis, and hemorrhage. However, no injuries or illnesses have been reported in the source text, placing it in the High category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Covidien, LP is recalling Tri-Staple 2.0 Black Intelligent Reload surgical stapler reloads (Product Number SIG60AXT) due to a mechanical defect in certain units. Affected devices have a broken sled vane that may prevent the reload from functioning properly during surgery.
When the device misfires, it may fail to close the staple line correctly, causing tissue to be cut without staples being placed. This can lead to serious complications during surgery, including delayed treatment, infection, blood loss, failure to properly connect tissues, inflammation, sepsis, collapsed lung, tissue damage, and potentially death.
A total of 264 units were distributed across the United States, including Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, and Washington. An additional 5,056 units were distributed internationally to countries including Australia, Austria, Belgium, Canada, and others. The affected lot numbers are N2D0002Y, N2D0004Y, and N2D0195Y.
The recalled product
- Product
- Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
- Manufacturer
- Covidien, LP
- Hazard
- device-malfunction
- surgical-failure
- tissue-trauma
- hemorrhage
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 (3)
- UDI-DI (GTIN): 20884521543598 Lots: N2D0002Y
- N2D0004Y
- N2D0195Y
Distribution
Distributed nationwide across the United States.
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