Abbott Vascular is voluntarily recalling 500 units of its MitraClip mitral valve repair system (Evalve), which is used to reduce mitral regurgitation and as an alternative to open-heart surgery for certain patients, after the company found problems with its delivery catheter system.
The recall focuses on three reported cases involving the delivery catheter system used to deploy the MitraClip system. In those cases, the radiopaque ring housed at the tip of the delivery catheter detached after the MitraClip was implanted, according to Jonathon D. Hamilton, Abbott spokesperson.
However, while Hamilton said that the ring detached during delivery, the procedure itself was not affected.
Abbott noted that patients already implanted with the MitraClip system are not affected by the recall, and stated that it is working to resolve this issue and will resume shipments as soon as possible.
The MitraClip device received the CE mark in 2008, but is still an investigative device in the U.S. By the conclusion of 2010, approximately 2,000 MitraClip implants had been performed worldwide.