CGuard Prime Carotid Stent System · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2026-05-01	Z-2325-2026	Class II	Open, Classified	Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Distribution: US Nationwide distribution 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.	190 units	clearance family
2026-05-01	Z-2326-2026	Class II	Open, Classified	Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Distribution: US Nationwide distribution 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.	424 units	clearance family
2026-05-01	Z-2327-2026	Class II	Open, Classified	Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Distribution: US Nationwide distribution 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.	147 units	clearance family
2026-05-01	Z-2328-2026	Class II	Open, Classified	Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Distribution: US Nationwide distribution 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.	291 units	clearance family
2026-05-01	Z-2329-2026	Class II	Open, Classified	Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Distribution: US Nationwide distribution 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.	114 units	code info di
2026-05-01	Z-2330-2026	Class II	Open, Classified	Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Distribution: US Nationwide distribution 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.	211 units	clearance family

Regulatory clearances

PMAP24002930-day notice accepted (OK30) · 2026-03-16 · +2 earlier decisionsclearance family

Manufacturer compliance record

None in the loaded window.

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