InspireMD initiates voluntary U.S. recall of CGuard Prime 135 cm system

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. “The Company acted after determining during a controlled launch that the technical success of the delivery system during carotid artery stenting procedures has not met performance expectations. This action is voluntary with no implications for the safety of patients who have previously received the CGuard stent. This voluntary action pertains specifically to the CGuard Prime 135 delivery system, and does not include the CGuard stent implant, which continues to generate unmatched clinical outcomes, including the lowest major adverse event rates and most durable stroke prevention among CAS carotid interventions. InspireMD anticipates FDA approval for its original CGuard stent delivery system for CAS procedures in the U.S. in the third quarter of 2026. The delivery system has been successfully used in over 70,000 cases worldwide, including the majority of clinical study cases in the CGUARDIANS clinical trial. The Company is also implementing design improvements to the CGuard Prime stent delivery system and anticipates FDA approval in the first half of 2027,” the company stated. “Our continued strong unit sales growth worldwide in the first quarter 2026 reflects significant demand for this novel stent technology with our best-in-class CGuard implant. However, the controlled launch of CGuard Prime in the U.S. has revealed opportunities to improve the technical performance of the delivery system. As a result, we have taken the proactive step to pause commercialization of the CGuard Prime delivery system to implement the necessary enhancements. This voluntary action reflects our unwavering commitment to providing our customers with the highest quality carotid stent platform on the market, while minimizing market disruptions and achieving the optimal physician satisfaction and patient safety for which we are known,” stated Marvin Slosman, Chief Executive Officer.