July 31, 2023 — Today, the U.S. Food and Drug Administration (FDA) is providing an update to the February 27, 2023 Letter to Health Care Providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta Valve and Trifecta Valve with Glide Technology (GT).
The manufacturer has announced its decision to stop selling and distributing Trifecta valves in the United States and has informed customers to return unused Trifecta valves. The FDA continues to work with the manufacturer to further evaluate the potential risk of early SVD in patients implanted with Trifecta valves.
On July 31, 2023, 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.
Read Abbott’s letterExternal Link Disclaimer that informs 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’s recommendations below have not changed, including the patient management considerations by Abbott for patients implanted with Trifecta valves.
The FDA 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.
You can read the original FDA statement here.
For more information: www.fda.gov
November 07, 2024 
