Covidien recalls specific Signia Small Diameter Curved Tip Intelligent Reload 30mm vascular staples due to potential safety interlock failure causing failed anastomosis and bleeding.
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 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.
The safety interlock is designed to prevent an empty single-use reload from being fired twice. If it fails, the stapler may fire an empty reload, causing tissue damage without deploying staples. This could lead to failed surgical connections, bleeding, and the need for open surgery.
Surgical professionals using the recalled Signia Small Diameter Curved Tip Intelligent Reload 30mm vascular staples for procedures. Patients undergoing surgery with these staples are at risk of bleeding or needing additional surgery.
Check for the Short Item Code SIGSDS30CTVT on the product. The recall includes specific lot numbers listed in the record and the UDI 10884521741874 or 20884521741871.
Verify the Short Item Code SIGSDS30CTVT and lot numbers listed in the recall notice.
The safety interlock might fail, causing the stapler to fire an empty reload and potentially leading to tissue damage, bleeding, and the need for open surgery.
Check the Short Item Code and lot numbers listed in the recall notice to confirm if your product is affected.
The recall does not specify a fix or remedy; the product must be checked against the listed lot numbers.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1385-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1385-2021 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.
