Home / Recalls / Medical Devices
Covidien, LP recalls Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Recalled April 10, 2024 · FDA recall Z-1458-2024 · Covidien
Hazard
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. · FDA Class II
Units
3,023 units
Sold at
Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
Description
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.
Product
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Manufacturer(s)
Covidien, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →