BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Worldwide Recall of the MitraClip System, Abbott Vascular, Evalve Inc.

Product group Non-active implants
Reference 01849/11

Abbott Vascular, Evalve Inc. (CA Menlo Park, USA) is conducting a worldwide recall of the whole MitraClip System.
The recall is based on the fact that the radiopaque marker of the delivery catheter had detached in three incidents.

Worldwide Recall of the MitraClip System, Abbott Vascular, Evalve Inc. , Download_VeroeffentlichtAm_EN PDF, 299KB, File does not meet accessibility standards