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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.
 

Important Information Regarding SVD in Trifecta Family of Valves – July, 2023

This communication is to inform customers that Abbott has discontinued its Trifecta family of valves and is initiating inventory-related activities in accordance with respective regulatory frameworks. An example of the communication is below. The exact communication format varies based on region. Additional educational information on long term care and SVD for patients implanted with Trifecta family of valves is available here.

CUSTOMER LETTER

 

Medical Device Field Safety Notice: Amplatzer™ Steerable Delivery Sheath – June, 2023

A field safety notice was issued in June 2023 due to the potential for air embolism specific to the hemostasis valve of the Amplatzer™ Steerable Delivery Sheath.

PHYSICIAN COMMUNICATION

 

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.
 
An example of the communication is below. The exact communication format varies based on region.

CUSTOMER LETTER

 

Medical Device Safety Notice: MitraClip and TriClip Delivery Systems

Abbott is sharing information about the use of the MitraClip and TriClip Delivery System(s). 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.

PHYSICIAN COMMUNICATION

MAT-2211061 v5.0 | Item approved for OUS use only.

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MAT-2000631 v18.0 | Item approved for OUS use only.

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