CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report

CGuard¿ Prime Carotid Stent System, 8mmx40mm recalled by Inspiremd

Inspiremd is recalling CGuard¿ Prime Carotid Stent System, 8mmx40mm, distributed nationwide in the US. The recall was initiated on 1 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 07290120281707; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026

Quantity recalled424 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2326-2026
FDA event ID: 98922
Recalling firm: Inspiremd, Miami, FL
Classification: Class II
Status: Ongoing
Recall initiated: 1 May 2026
FDA classified: 5 Jun 2026
Reported: 17 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

1 May 2026	Recall initiated by company
5 Jun 2026	Classified by FDA	+35 days
17 Jun 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

Where it was distributed

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.

Nationwide Arkansas Arizona California District of Columbia Florida Georgia Hawaii Illinois Indiana Kansas Massachusetts Maryland Michigan Missouri North Carolina New Jersey Nevada New York Ohio Oregon

Questions about this recall

Is CGuard¿ Prime Carotid Stent System, 8mmx40mm recalled?

Yes. Inspiremd recalled CGuard¿ Prime Carotid Stent System, 8mmx40mm on 1 May 2026. The recall is Class II and its status is Ongoing. Recall number Z-2326-2026.

Why was it recalled?

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

Which lots are affected?

UDI: 07290120281707; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Inspiremd

All 6

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Device	CLASS II	CGuard Prime Carotid Stent System, 10mmx30mm recalled by Inspiremd	Inspiremd	Other	Nationwide
17 Jun 2026Device	CLASS II	CGuard Prime Carotid Stent System, 9mx40mm recalled by Inspiremd	Inspiremd	Other	Nationwide
17 Jun 2026Device	CLASS II	CGuard¿ Prime Carotid Stent System, 10mmx40mm recalled by Inspiremd	Inspiremd	Other	Nationwide
17 Jun 2026Device	CLASS II	CGuard Prime Carotid Stent System, 9mx30mm recalled by Inspiremd	Inspiremd	Other	Nationwide
17 Jun 2026Device	CLASS II	CGuard¿ Prime Carotid Stent System, 8mmx30mm recalled by Inspiremd	Inspiremd	Other	Nationwide

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16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide