Covidien recalls specific Signia Small Diameter Curved Tip Intelligent Reload staplers due to potential safety interlock failure, which may cause tissue trauma or bleeding during surgery.
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.
Covidien is recalling certain Signia Small Diameter Curved Tip Intelligent Reload staplers because their safety interlock might fail, leading to a failed anastomosis, bleeding, or tissue damage during surgery. This could require a switch to an open surgical procedure.
The safety interlock is designed to prevent an empty single-use reload from being fired twice. If it fails, the stapler may cut tissue but not deploy staples, causing a failed connection between blood vessels, bleeding, or tissue injury that might require open surgery.
Surgical staff using the recalled Signia Small Diameter Curved Tip Intelligent Reload staplers for vascular procedures are most at risk. Patients undergoing surgery with these devices may experience complications.
Check for the item code SIGSDL45CTVT on the device. The lot numbers listed include N0A1038UY through N9L0797UY. The unique device identifier (UDI) is 10884521741843 or 20884521741840.
Identify the item code (SIGSDL45CTVT) and lot numbers (N0A1038UY to N9L0797UY) to confirm if your device is recalled.
The safety interlock in the stapler could fail, causing the device to fire an empty reload twice. This may result in tissue trauma, bleeding, or the need for open surgery.
Check the item code and lot numbers listed in the recall notice to determine if your device is affected. If it is, contact Covidien for further instructions.
The recall notice does not specify a remedy; users should check if their device is affected and contact the manufacturer for guidance.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1383-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1383-2021 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.
