Covidien recalls Signia Small Diameter Curved Tip Intelligent Reload Model SIGSDS30CTVT due to potential uncontrolled articulation during use, which could disrupt staple lines. Affected users should contact for details.
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
Covidien is recalling a specific surgical staple reload model because it can move unpredictably during use, potentially disrupting the staple line. This could lead to complications during medical procedures if the device is used without proper control.
The reloads can move unexpectedly during use due to components that aren't securely attached. This uncontrolled movement might disrupt the staple line, which is critical for surgical procedures. If the device moves unexpectedly, it could cause complications during surgery.
Surgical professionals using the Signia Small Diameter Curved Tip Intelligent Reload Model SIGSD:30CTVT with Endo GIA Ultra Universal Stapler or Signia Stapling System are most at risk. Patients undergoing procedures with these devices may also be affected.
Check for the model number SIGSDS30CTVT on the reload. The product was sold with Endo GIA Ultra Universal Stapler or Signia Stapling System. The UDI/DI number 10884521741881 and lot number N3L1909UY are also associated with this recall.
Identify the model number SIGSDS30CTVT on the reload to confirm if it's affected.
Reach out to Covidien for specific instructions on how to handle the recalled item.
The model number is SIGSDS30CTVT.
The recalled reload is used with Endo GIA Ultra Universal Stapler or Signia Stapling System.
The recall record does not mention a fix or remedy.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1457-2024 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1457-2024 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.
