Recall Z-1458-2024 ยท GDW Staple, Implantable
Covidien, LP
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
| Date | Apr 1, 2024 (initiated Feb 14, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On February 14, 2024, the firm notified domestic customers and notified international customers starting February 19, 2024 of the issue via URGENT: MEDICAL DEVICE RECALL letters. Actions to be taken by the customer: 1. Identify and quarantine all unused impacted product listed above. 2. See Attachment A for guidance on identifying affected lots. 3. Return all quarantined devices to Medtronic. Please contact rs.covidienfeedbackcustomerservice@medtronic.com for the Return Goods Authorization (RGA). 4. Credit for the returned affected devices will be issued based on the RGA number. 5. If purchase |
| Quantity | 3,023 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191070 | Signia Small Diameter Reloads Covidien, Sep 4, 2019 |