Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
Check against the official notice below — it lists the full affected range.
Covidien, LP is recalling the Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm stapler due to a potential failure of the device safety interlock. This safety feature is designed to prevent an empty reload from being fired twice. If the interlock fails and the empty reload is fired a second time, the stapler may cut tissue without deploying staples, potentially causing failed anastomosis, bleeding, tissue trauma, and the possible need to convert to an open surgical procedure.
The recall affects 11,391 units worldwide, including 5,982 units in the United States and 5,409 units distributed internationally to 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 devices are identified by 16 specific lot numbers and the provided UDI codes. The source document does not specify what remedy an affected consumer 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: 11391 units WW: 5982 US 5409 OUS Lot/code info: Lot Numbers: N0A0191UY N0D0392UY N0F0406UY N0L0708UY N0B0657UY N0E0133UY N0G0907UY N9K0376UY N0C0349UY N0E0956UY N0J0746UY N9K1093UY N0C0492UY N0E1026UY N0K0248UY N9L0796UY N0C1008UY N0F0202UY N0K0803UY N9M0418UY N0D0283UY N0F0221UY N0L0307UY N9M0651UY UDI: 10884521741881 20884521741888
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.