InspireMD Initiates Voluntary U.S. Recall of CGuard® Prime 135 cm Carotid Stent Delivery System

InspireMD, Inc. has announced a voluntary recall of its CGuard® Prime 135 cm carotid stent delivery system after recognizing that its technical performance during carotid artery stenting procedures did not meet expectations. This action, taken in consultation with the FDA, does not affect patient safety for those who have already received the stent. The company is also making design improvements to this system and anticipates FDA approval for a related 80 cm delivery system for TCAR procedures later this year.