FDA Device Intelligence
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Stent, Carotid

FDA product code NIM · Class 3 · Unknown

216
Registered devices
8,649
Adverse events
25
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-06-29Contego Medical, IncCarotid 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
2026-05-01INSPIREMD IncStent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
2026-05-01INSPIREMD IncStent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
2026-05-01INSPIREMD IncStent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
2026-05-01INSPIREMD IncStent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
2026-05-01INSPIREMD IncStent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
2026-05-01INSPIREMD IncStent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
2025-09-04Contego Medical LLCCarotid 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
2025-07-07Boston Scientific CorporationCertain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting
2021-02-11Cordis CorporationDistal tip may become separated from the lumen wire in specific lots.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.