InspireMD recently shared that, in consultation with the US Food and Drug Administration (FDA), the company has initiated a voluntary recall in the USA for its CGuard Prime 135cm carotid stent delivery system.
According to a press release, InspireMD acted after determining during a controlled launch that the technical success of the delivery system during carotid artery stenting (CAS) procedures has not met performance expectations. The company notes that 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. It does not include the CGuard stent implant, which, the company states, “continues to generate unmatched clinical outcomes, including the lowest major adverse event rates and most durable stroke prevention among CAS carotid interventions”.
InspireMD anticipates US FDA approval for its original CGuard stent delivery system for CAS procedures in the USA in the third quarter of 2026, also highlighting that the delivery system has been successfully used in over 70,000 cases worldwide, including the majority of clinical study cases in the CGUARDIANS trial.
The company is implementing design improvements to the CGuard Prime stent delivery system and anticipates US FDA approval in the first half of 2027.
“Our continued strong unit sales growth worldwide in the first quarter [of] 2026 reflects significant demand for this novel stent technology with our best-in-class CGuard implant,” stated InspireMD chief executive officer (CEO) Marvin Slosman. “However, the controlled launch of CGuard Prime in the USA has revealed opportunities to improve the technical performance of the delivery system. As a result, we have taken the proactive step to pause commercialisation 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 minimising market disruptions and achieving the optimal physician satisfaction and patient safety for which we are known.”
As noted in a press release, InspireMD expects US FDA approval later this year for its CGuard Prime 80cm carotid stent delivery system for transcarotid artery revascularisation (TCAR) procedures, designed to be compatible with neuroprotection systems that are already in use. Additionally, the company anticipates potential US FDA clearance of its SwitchGuard neuroprotection system for TCAR procedures in the second half of 2027.
