InspireMD (NSPR) announced that, in consultation with the U.S. Food and Drug Administration, the company has initiated a voluntary recall in the U.S. for its CGuard Prime 135 cm carotid stent delivery system. “Concurrent with today’s announcement, the Company is withdrawing its prior full year 2026 revenue guidance. Management believes this is the most prudent step given the impact of the temporary discontinuation of commercial activity in the U.S. pending the anticipated FDA approval of its original CGuard stent delivery system in the third quarter of 2026. Management intends to provide a full company update on this and other recent developments during its conference call for the results of the first quarter of 2026 on May 4,” the company stated.
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