openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Code information
UDI: 07290120281691; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Distribution pattern
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.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Code information
UDI: 07290120281707; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Distribution pattern
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.
device · product 3 of 6
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Code information
UDI: 07290120281738; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Distribution pattern
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.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Code information
UDI: 07290120281745; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Distribution pattern
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.
device · product 5 of 6
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Code information
UDI: 07290120281776; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Distribution pattern
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.
device · product 6 of 6
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Code information
UDI: 07290120281783; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Distribution pattern
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.
