Product Advisories
IMPORTANT PRODUCT INFORMATION
We pursue excellence in every product we make. We have a strong history of product safety and reliability, and we remain dedicated to developing technology and products that save and improve the lives of patients worldwide.
We take our responsibilities as a leading device manufacturer very seriously and recognize our primary responsibility is to ensure that our devices are of the highest quality and function safely and properly.
Our commitment to business integrity means we quickly share with professionals and patients the important information they need about our products’ performance and safety. These product advisories and communications remain available for review.
Medical Device Recall: Amplatzer™ TorqVue™ LP Delivery System (TVLP) and Amplatzer ™ TorqVue™ LP Catheter (TVLPC) - March 2025
Abbott is notifying customers of an issue related to certain 4F Amplatzer™ TorqVue™ LP Delivery System (TVLP) and 4F Amplatzer™ TorqVue™ LP Catheter (TVLPC) with a potential for a small leak to occur on the catheter shaft.
Update to Important Information Regarding SVD in Trifecta Family of Valves – July, 2023
An update was issued to the February 2023 communication for the Trifecta family of valves. This communication is to inform customers that Abbott is initiating a US Market Withdrawal for the Trifecta family of valves and will be removing the limited remaining inventory from the field. Additional educational information on long term care and SVD for patients implanted with Trifecta family of valves is available here.
Medical Device Recall: Amplatzer™ Steerable Delivery Sheath – June, 2023
A recall notification was issued to customers in June 2023 due to the potential for air embolism specific to the hemostasis valve of the Amplatzer™ Steerable Delivery Sheath.
Important Information Regarding SVD in Trifecta Family of Valves – February, 2023
Abbott is providing information regarding Structural Valve Deterioration (SVD) related to its Trifecta family of bioprosthetic heart valves. This communication is intended to raise awareness regarding the potential for early SVD and provide patient management considerations.
Medical Device Correction: MitraClip Delivery System – September, 2022
Abbott is sharing information about the use of the MitraClip Delivery System. Abbott has observed an increase in complaints regarding Clip locking malfunctions. This communication is to bring awareness, share the actions Abbott is taking, and emphasize the relevant steps of the Instructions for Use (IFU) to aid in optimal function of the Clip locking mechanism.
MAT-2210982 v8.0 | Item approved for U.S. use only.