InspireMD has issued a voluntary recall of its CGuard Prime 135cm carotid stent delivery system in the US, following consultation with the US Food and Drug Administration (FDA).
The decision follows a controlled launch that revealed the delivery system’s technical performance during carotid artery stenting procedures did not meet expectations.
The recall does not affect patients who have already received the CGuard stent, and no safety concerns have been identified.
The recall is limited to the CGuard Prime 135cm delivery system and does not involve the CGuard stent implant.
According to InspireMD, the implant continues to deliver favourable clinical outcomes, maintaining low rates of major adverse events and providing durable stroke prevention compared to other carotid artery stenting (CAS) options.
InspireMD expects to secure FDA approval for its original CGuard stent delivery system for CAS procedures in the US by the third quarter of 2026.
Globally, this delivery system has supported more than 70,000 procedures, including those in the CGUARDIANS clinical trial.
The company is working on design improvements for the CGuard Prime stent delivery system and aims for FDA approval in the first half of 2027.
InspireMD CEO Marvin Slosman said: “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 US 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.”
InspireMD also expects FDA approval this year for its CGuard Prime 80 cm carotid stent delivery system for transcarotid artery revascularisation (TCAR) procedures, compatible with current neuroprotection systems.
An approved TCAR indication could potentially double the addressable market for the CGuard stent implant, with technical performance of the 80 cm device meeting expectations.
FDA clearance for the SwitchGuard neuroprotection system for TCAR procedures is anticipated in the second half of 2027.
In June 2025, InspireMD’s CGuard Prime Embolic Prevention System (EPS) secured CE Mark approval under the European Medical Device Regulation (MDR) for stroke prevention.
