Recall Z-1457-2024— Covidien, LP
Class II · Ongoing
Class II FDA medical device recall by Covidien, LP, initiated 2024-02-14. It names one FDA 510(k) clearance: K191070. Product: Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT. Reason: 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
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-14
- Firm location
- North Haven, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.