Covidien recalls SIGNIA TRI-STAPLE 2.0 devices that may cause bleeding or infection due to missing pin components. Affected models include SIG45CTAMT and others listed in the recall.
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
Covidien is recalling SIGNIA TRI-STAPLE 2.0 surgical staples that may not form properly due to missing pins, leading to bleeding or infection risks. This affects surgeons and medical staff using the specific model numbers listed in the recall.
The device may be missing one of two pin components that keep the staple jaws aligned. Without proper alignment, staples may not form correctly, causing bleeding, infections, or serious complications like peritonitis or pneumothorax.
Surgeons and medical staff who use the SIGNIA TRI-STAPLE 2.0 devices for surgical procedures are most at risk. The recall applies to specific model numbers used in the U.S. healthcare system.
Check if your device has the model numbers listed in the recall, such as SIG45CTAMT, N6E0296UX, or other codes ending in UX or Y. These models were sold for surgical use in the U.S.
Identify your device model by checking the label on the device, which includes codes like SIG45CTAMT or N6E0296UX.
Reach out to Covidien directly for guidance on whether your device is affected and what steps to take next.
The device may cause incomplete staple formation due to missing pin components, leading to bleeding, infection, or serious complications like peritonitis or pneumothorax.
Affected models include SIG45CTAMT and other codes listed in the recall, such as N6E0296UX, N6J1034UX, and others ending in UX or Y.
The recall does not require immediate discontinuation; however, affected devices should be checked for proper function and reported to the manufacturer if needed.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1835-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1835-2019 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
