Medical Device Recall: Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Covidien, LP · February 14, 2024
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
States Affected
NATIONWIDE
Quantity Affected
3,023 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1458-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.