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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.
 

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 v1.0 | 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.
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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 v10.0 | Item approved for OUS use only.

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