Recall Z-1383-2021 ยท GDW Staple, Implantable
Covidien, LP
Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
| Date | Mar 4, 2021 |
| Status | Terminated |
| Reason | Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure. |
| Root cause | Under Investigation by firm |
| Action | Covidien/Medtronic issued Urgent Medical Device Recall via Federal Express and/or certified mail beginning March 4, 2021, states reason for recall, health risk and action to take: 1. Please immediately quarantine and discontinue use of affected item codes with associated lot numbers listed on Attachment A. 2. Please return affected product as indicated below. All unused products from the affected item codes and associated lot numbers must be returned. 3. If you have distributed the Covidien Signia" small diameter curved tip intelligent reload listed on Attachment A, please promptly forward the |
| Quantity | 5928 units WW: 4212 US 1716 OUS |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191070 | Signia Small Diameter Reloads Covidien, Sep 4, 2019 |