Facility

INSPIREMD, LTD.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3031658894
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	4 Menorat HaMaor Street Tel Aviv, IL 67448
Registration status	Active · expires 2026
Parent company	InspireMD, Ltd. (owner-operator 10093698)
Brand names	CGuard Prime Carotid Stent System

Activity by year

Recalls (1)

Devices registered here (1)

Stent, Carotid
Product code NIM (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2026-05-01
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

All facilities operated by InspireMD, Ltd.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “INSPIREMD, LTD. (FEI 3031658894) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3031658894-inspiremd-ltd/

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