Initiated a voluntary U.S. recall of the CGuard Prime 135 cm carotid stent delivery system following performance issues identified during a controlled launch. The recall is limited to the delivery system and does not affect the CGuard stent implant itself. Withdrew full-year 2026 revenue guidance due to the temporary discontinuation of U.S. commercial activity for the affected product. Received FDA approval for the Investigational Device Exemption (IDE) to initiate the CGUARDIANS III pivotal study for the SwitchGuard neuro protection system. Anticipates FDA approval for the original CGuard delivery system in Q3 2026 and the CGuard Prime 80 cm system for TCAR procedures in 2H 2026.