Abbott announced its decision to stop selling and distributing Trifecta valves, which include the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), in the United States.
The company informed customers to return to Abbott any Trifecta valves that have not been implanted and provides Unique Device Identifier (UDI) information for these valves.
The FDA said it continues to work with Abbott to further evaluate the potential risk of early structural valve deterioration (SVD) in patients implanted with Trifecta valves and will keep the public informed if there are any new recommendations.
Earlier this year, the FDA began informing health care providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which feature leaflets externally mounted to the valve frame.
