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Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jun 17, 2026

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

Full official product description

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840 | Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830 | CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930 | CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040 | Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940 | CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 1, 2026, 8:43 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840; Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830; plus 4 additional official variants listed below.

Identifiers to compare

  • UDI 07290120281707
  • UDI 07290120281691
  • UDI 07290120281738
  • UDI 07290120281783
  • UDI 07290120281745
  • UDI 07290120281776
  • Serial numbers
  • Lot s/serial
  • Lot 02/23/2026

6 official variants

Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840UDI: 07290120281707; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026424 unitsZ-2326-2026
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830UDI: 07290120281691; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026190 unitsZ-2325-2026
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930UDI: 07290120281738; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026147 unitsZ-2327-2026
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040UDI: 07290120281783; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026211 unitsZ-2330-2026
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940UDI: 07290120281745; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026291 unitsZ-2328-2026
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030UDI: 07290120281776; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026114 unitsZ-2329-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

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.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

  • : affectedSummary changed in the official record.