CGuard Prime Carotid Stent System Recall Issued
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
INSPIREMD Inc has initiated a Class II recall of 147 units of the CGuard Prime Carotid Stent System due to potential deployment complications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 28, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
INSPIREMD Inc has initiated a voluntary recall of the CGuard Prime Carotid Stent System because the stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Which Products Are Affected
CGuard Prime Carotid Stent System, 135cm, 9mx30mm, Model/Catalog Number: CND0930. UDI: 07290120281738. All lots/serial numbers manufactured between 02/03/2025 and 02/23/2026. A total of 147 units were distributed to US Nationwide locations in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV. Recall number Z-2327-2026.
What You Should Do
Contact the recalling firm INSPIREMD Inc regarding the affected products.
Why This Matters
The recall addresses a Class II issue involving potential complications with stent deployment in a medical device distributed across multiple states.
Source
FDA recall number Z-2327-2026, report date 20260617.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,014 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 28, 2026.
Frequently Asked Questions
Common questions about this FDA recall.