FDA recall Z-1458-2024

Covidien, LP · Class II · device

Product

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.

Distribution

Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.

Key facts

Status
Ongoing
Initiation date
2024-02-14
Report date
2024-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1458-2024