Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
Check against the official notice below — it lists the full affected range.
Covidien, LP is recalling the Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm surgical stapler device due to a potential failure of the device's safety interlock. This safety feature is designed to prevent an empty reload from being fired a second time. If the interlock fails and the empty reload is fired again, the stapler may cut tissue without deploying staples, which could result in failed connections between tissues, bleeding, tissue damage, and the need to convert to an open surgical procedure. The recall affects 15,298 units worldwide, including 9,204 units in the United States, distributed across numerous countries including Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.
The affected device was distributed under specific lot numbers and a UDI code. According to the recall record provided, no remedy is specified for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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. Quantity: 15298 units WW: 9204 US; 6094 OUS Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.