FDA Upgrades J&J MedTech CEREPAK Recall to Class I After Fatal Incident

FDA Classifies J&J; MedTech's CEREPAK Recall as Class I Following Patient Death In a significant development for the medical device industry, the U.S. Food and Drug Administration (FDA) has upgraded the recall of Johnson & Johnson MedTech’s CEREPAK embolic protection system to a Class I recall, the most serious type of recall, after a patient death was linked to the device. This action underscores the agency’s commitment to patient safety and highlights the potential risks associated with neurovascular interventions. Background on the CEREPAK Device The CEREPAK system is designed to protect brain tissue during endovascular procedures, such as carotid artery stenting, by capturing dislodged plaque and debris that could otherwise cause a stroke. The device consists of a distal filter basket and a proximal occlusion balloon, which work together to isolate the treatment zone and prevent embolic material from traveling downstream. Since its introduction, CEREPAK has been marketed as