FDA Device recall Z-1385-2021
Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
- FDA Device
- Class II
- terminated
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class II recall of Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT by Covidien, citing 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 fai….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1385-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-04 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | US |
Product
Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
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.
Identifiers
| code_info | Lot Numbers: N0A0274UY N0D0037UY N0G0491UY N0K1016UY N0A0897UY N0D0391UY N0G0736UY N0L0077UY N0B0640UY N0E017…Lot Numbers: N0A0274UY N0D0037UY N0G0491UY N0K1016UY N0A0897UY N0D0391UY N0G0736UY N0L0077UY N0B0640UY N0E0175UY N0J0510UY N0M0063UY N0B0937UY N0E0802UY N0J0680UY N0M0259UY N0C0144UY N0F1055UY N0J0999UY N9K1094UY N0C0486UY N0G0185UY N0K0584UY N9L0795UY N0C1115UY N0G0250UY N0K0805UY UDI: 10884521741874 20884521741871 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1385-2021%22
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