Covidien recalls specific Signia Grey Small Diameter Curved Tip Intelligent Reload 30mm vascular staples due to potential safety interlock failure, which may cause failed anastomosis and 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 Grey Small Diameter Curved Tip Intelligent Reload 30mm vascular staples because their safety interlock might fail. If this happens, the stapler could fire an empty reload, causing tissue damage, bleeding, and requiring surgery to be converted to an open procedure.
The safety interlock is designed to prevent an empty single-use reload from being fired a second time. If it fails, the stapler may cut tissue but no staples will deploy, leading to failed anastomosis, bleeding, and potential need for open surgery.
Surgical professionals using the recalled Signia Grey Small Diameter Curved Tip Intelligent Reload 30mm vascular staples for vascular anastomosis procedures are most at risk. Patients undergoing such surgeries with the affected product could experience complications.
Check for the Short Item Code SIGSDS30CTV on the product. Affected units have specific lot numbers listed in the recall notice and a unique device identifier (UDI) starting with 10884521741881 or 20884521741888.
Verify the Short Item Code SIGSDS30CTV and lot numbers listed in the recall notice to confirm if your device is affected.
The safety interlock in the device may fail, causing the stapler to fire an empty reload which can result in failed anastomosis, bleeding, and the need for open surgery.
The recall does not specify a remedy, so check the product details to see if it is affected and contact the manufacturer for further instructions.
Look for the Short Item Code SIGSDS30CTV and check the lot numbers listed in the recall notice, which include specific codes like N0A0191UY and UDI starting with 10884521741881 or 20884521741888.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1384-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1384-2021 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.
