Covidien recalls Tri-Staple 2.0 Black Intelligent Reload (SIG60AXT) due to potential broken sled vane causing misfire and tissue damage. Affected lots may lead to delayed treatment, bleeding, or death.
Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.
Covidien is recalling Tri-Staple 2.0 Black Intelligent Reload devices with specific product numbers because a broken sled vane can cause the device to misfire. This may result in tissue damage, bleeding, or death if the device fails to properly close the staple line during surgery.
The device has a potential for a broken sled vane, which can cause the reload to misfire. This means the staple line may not close properly, leading to tissue being cut without forming staples or causing tissue to hang up. These issues could delay treatment, cause bleeding, infection, or death.
Surgical staff using the Tri-Staple 2.0 Black Intelligent Reload device with product numbers SIG60AXT lots N2D0002Y, N2D0004Y, and N2D00195Y are most at risk. Patients undergoing procedures with this device could face serious complications.
Check for the product number SIG60AXT on the device. Affected lots are N2D0002Y, N2D0004Y, and N2D00195Y. The device was sold with UDI-DI (GTIN) 20884521543598.
Immediately stop using the Tri-Staple 2.0 Black Intelligent Reload device if it has the affected product numbers.
Affected lots are N2D0002Y, N2D0004Y, and N2D00195Y.
The device may misfire, causing tissue damage, bleeding, infection, or death.
Check the product number on the device; affected lots are N2D0002Y, N2D0004Y, and N2D00195Y.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1228-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1228-2023 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.
