The FDA has posted 9 enforcement recalls of carotid stent devices since 2025, including 1 Class I (most serious) recall. Most recent report: Aug 12, 2026.
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction;…
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob.…
Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidew…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Stent, Carotid”). Informational only — verify against the FDA before acting.