Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
Check against the official notice below — it lists the full affected range.
Covidien is recalling approximately 5,928 units of its Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm surgical stapler worldwide, including 4,212 units in the US. The devices contain a safety interlock designed to prevent an empty reload from being fired twice. This interlock may fail, allowing the stapler to fire a second time from an empty reload, which would cut tissue without deploying staples and could result in failed tissue connection, bleeding, and tissue damage requiring conversion to open surgery.
The recalled devices were distributed worldwide to the US and multiple 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 recall affects specific lot numbers beginning with N0A, N0E, N0F, N0K, N0B, N0G, N9K, N0D, and N9L. The source does not specify what action affected consumers should take.
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: 5928 units WW: 4212 US 1716 OUS Lot/code info: Lot Numbers: N0A1038UY N0E0016UY N0F0616UY N0K0934UY N0B0493UY N0F0254UY N0F0817UY N0M0334UY N0C0436UY N0F0518UY N0G0388UY N9K1095UY N0D0731UY N0F0615UY N0J0859UY N9L0797UY UDI: 10884521741843 20884521741840
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.