Abbott voluntarily recalls MitraClip

Kaitlyn Dmyterko | | Cardiovascular Business | Interventional Cardiology
MitraClip System
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.

Kaitlyn Dmyterko

Related Content

Surgery outperforms PCI in NSTEMI patients with multivessel CAD
Boston Scientific enters IVL arms race with acquisition worth up to $664M
FDA sees value in no-implant heart failure device
Radial secondary access during TAVR limits complications
Medtronic’s Harmony TPVR system gains CE mark approval
History made: Young child treated with new heart device for very first time

Around the web

Radiology Business
Key takeaways from RSNA 2024 for AI, CT, MRI and the radiology staffing shortage

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.