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INSPIREMD Inc FDA Recalls

6 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830Class IIMay 1, 2026Stent delivery system may encounter complications during dep
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040Class IIMay 1, 2026Stent delivery system may encounter complications during dep
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840Class IIMay 1, 2026Stent delivery system may encounter complications during dep
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930Class IIMay 1, 2026Stent delivery system may encounter complications during dep
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030Class IIMay 1, 2026Stent delivery system may encounter complications during dep
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940Class IIMay 1, 2026Stent delivery system may encounter complications during dep

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