Edwards Lifesciences is recalling all lot numbers of the EMBOL-X Glide Protection System due to a deformed cannula tip. The affected EMBOL-X Glide Protection System was manufactured from September 21, 2010, through July 12, 2013, and distributed from September 21, 2010, through August 22, 2013.
The EMBOL-X access device system was designed to help capture material such as blood clots or tissue fragments during short-term (equal to or less than six hours) cardiopulmonary bypass surgery when surgeons may need to introduce and remove devices into the vascular system.
Use of this recalled product may cause serious adverse health consequences, including death.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Recall Announcement
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues
See also Medical Law Perspectives, December 2013 Report (to be published Dec. 4, 2013): When Blood Clots Cause Injury or Death