Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
FDA Recall #Z-1458-2024 — Class II — February 14, 2024
Product Description
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
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.
Recalling Firm
Covidien, LP — North Haven, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,023 units
Distribution
Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
Code Information
Model Number: SIGSDS30CTVT; UDI/DI: 10884521741888; Lot numbers: N3L1909UY, N3L1868UY, N3L2008UY, N3L2221UY, N3M1541UY, N3M1603UY, N3M1639UY;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated