InspireMD, Ltd.
US Last updated 23 May 2026
- Devices
- 7
- Registries
- GUDIDFDA PMAFDA
- FDA recalls
- 66 ongoing
Catalogue
CGuard Prime Carotid Stent System CND0930 Ref CND0930
CGuard Prime Carotid Stent System CND1040 Ref CND1040
CGuard Prime Carotid Stent System CND1030 Ref CND1030
CGuard Prime Carotid Stent System CND0940 Ref CND0940
CGuard Prime Carotid Stent System CND0840 Ref CND0840
CGuard Prime Carotid Stent System CND0830 Ref CND0830
CGuard™ Prime Carotid Stent System Ref P240029
FDA recalls
2026
- 1 May 2026 Z-2325-2026 Class II Ongoing Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- 1 May 2026 Z-2326-2026 Class II Ongoing Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- 1 May 2026 Z-2327-2026 Class II Ongoing Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- 1 May 2026 Z-2328-2026 Class II Ongoing Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- 1 May 2026 Z-2329-2026 Class II Ongoing Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- 1 May 2026 Z-2330-2026 Class II Ongoing Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
FDA establishments
- Inspiremd, Ltd. Tel Aviv · IL FEI 3031658894
What InspireMD, Ltd. makes
InspireMD, Ltd. manufactures mesh-sleeve carotid artery stents designed to treat narrowing or blockages in the carotid arteries. The company’s primary product is the CGuard Prime Carotid Stent System, which is intended for endovascular placement to restore blood flow in affected vessels.
The CGuard Prime Carotid Stent System is classified as a Class III medical device under US regulations. It is listed in the FDA’s Premarket Approval (PMA) and Unique Device Identifier (UDI) databases, reflecting its authorised status for carotid artery interventions. The company is based in the United States.
Frequently asked questions
What types of medical devices does InspireMD, Ltd. manufacture?
InspireMD, Ltd. specialises in mesh-sleeve carotid artery stents. These devices are designed to treat narrowing or blockages in the carotid arteries, which supply blood to the brain. The primary focus is on restoring blood flow through endovascular procedures, ensuring proper vascular function.
Where is InspireMD, Ltd. based?
InspireMD, Ltd. is headquartered in the United States. The company’s location is relevant for regulatory oversight and compliance with US medical device regulations, including those governing carotid artery stents.
How are InspireMD, Ltd.’s devices classified under US regulations?
InspireMD, Ltd.’s mesh-sleeve carotid artery stents, such as the CGuard Prime Carotid Stent System, are classified as Class III devices under US regulations. This classification applies to devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices require pre-market approval (PMA) due to their higher risk profile.
Which regulatory registries or databases list InspireMD, Ltd.’s devices?
InspireMD, Ltd.’s devices, including the CGuard Prime Carotid Stent System, are listed in the FDA’s Premarket Approval (PMA) database and the FDA’s Unique Device Identifier (UDI) system. These registries confirm the device’s authorised status for use in carotid artery interventions, ensuring traceability and compliance with US regulatory requirements.
Why is the CGuard Prime Carotid Stent System authorised under a PMA?
The CGuard Prime Carotid Stent System is authorised under a Premarket Approval (PMA) because it falls under Class III classification. This classification is reserved for devices that pose a significant risk to patients if they malfunction, such as those used in critical vascular procedures like carotid artery stenting. PMAs require rigorous clinical data to demonstrate safety and effectiveness, reflecting the higher scrutiny needed for such high-risk interventions.
Information
- Country
- US