InspireMD recalls CGuard Prime 135 cm stent delivery system in US due to performance issues, pauses sales.

InspireMD has voluntarily recalled its CGuard Prime 135 cm carotid stent delivery system in the US after performance issues were identified during a controlled launch. The recall does not affect the CGuard stent implant itself, which continues to show strong clinical results. The company plans to improve the delivery system design and expects FDA approval for the original CGuard delivery system in Q3 2026, with further approvals for related products anticipated in 2026 and 2027. InspireMD has withdrawn its 2026 revenue guidance due to the temporary sales pause but continues to see strong global demand for its stent technology.