InspireMD Announces Recall of CGuard® Prime Delivery System and FDA Approval for SwitchGuard IDE

InspireMD, Inc. has initiated a voluntary recall in the U.S. of its CGuard® Prime 135 cm carotid stent delivery system due to performance expectations not being met during a controlled launch. This recall specifically affects the delivery system and not the CGuard stent implant. The company anticipates FDA approval for its original CGuard stent delivery system in Q3 2026 and is working on design improvements for the CGuard Prime delivery system, with expected FDA approval in the first half of 2027. Concurrently, InspireMD announced that the FDA has approved its Investigational Device Exemption (IDE) application for the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system (NPS) for use with the CGuard Prime 80 cm stent platform in TCAR procedures. The company is withdrawing its prior full year 2026 revenue guidance due to the temporary discontinuation of commercial activity in the U.S.