InspireMD recalls CGuard Prime stent system and withdraws revenue guidance

8 articles · Updated · MarketWatch · May 1

The voluntary recall covers the 135 cm carotid stent delivery system used to help prevent stroke during carotid artery stenting procedures.
The company said the device failed to meet performance expectations in procedures and is now making design improvements.
InspireMD said it expects US Food and Drug Administration approval for the updated system in the first half of 2027.

An FDA-approved stroke device was just recalled. Does this expose a dangerous flaw in our medical safety net?

As a small firm's device fails, how will industry titans capitalize on the billion-dollar stroke prevention market?