Abbot Recalls 500 MitraClips Worldwide

New York, NY: Abbot has announced a recall of approximately 500 MitraClip mitral valve repair systems following three reported incidences of detachment of the radiopaque ring from the delivery catheter, all of which occured while the delivery catheter system was being removed following implantation.

Abbot is not recalling previously implanted MitraClip devices, according to media reports.

The MitraClip is designed to repair leaky mitral valves in patients with severe mitral regurgitation. The recall was issued for 500 devices used in residents of all countries where MitraClip is commercially available, and in the US where it is available through clinical trials.

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Published on May-10-11