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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 – 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 v2.0 | Item approved for OUS use only.

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Caution: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs. Photos on file at Abbott.
Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates.
No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

MAT-2000631 v14.0 | Item approved for OUS use only.

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