InspireMD

The CGuard Prime Carotid Stent System (model CND1040, 10mm×40mm) may encounter complications during deployment, including high resistance or inability to deploy the stent properly. This affects 211 units manufactured between February 3 and February 23, 2026, distributed across the United States.

The CGuard Prime Carotid Stent System (model CND1030, 10mm x 30mm) may be difficult or impossible to deploy during surgery due to complications in the delivery system. This affects 114 units manufactured between February 3 and February 23, 2026. No injuries have been reported.

The CGuard Prime Carotid Stent System (model CND0940, 9mm × 40mm, 135cm length) may experience difficulty during placement in the artery. The delivery system could encounter high resistance or fail to deploy the stent properly.

The CGuard Prime Carotid Stent System (model CND0930, 135cm) may experience complications during deployment that could result in high resistance or inability to place the stent. This affects 147 units manufactured between February 3, 2025 and February 23, 2026, distributed nationwide.

The CGuard Prime Carotid Stent System (model CND0840, 8mm×40mm) may experience high resistance or fail to deploy properly during the placement procedure. This affects 424 units manufactured between early February 2025 and February 2026.

InspireMD's CGuard Prime Carotid Stent System (model CND0830, 8mm×30mm) may experience complications during deployment that could make it difficult or impossible to place the stent. About 190 units were distributed nationwide between February 2025 and February 2026. No injuries have been reported so far.