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Carotid WALLSTENT®

BOSTON SCIENTIFIC CORPORATION · Model M001719050 · UDI-DI 08714729781127

NIM Prescription

510(k) clearances

8,649

Adverse events (695 deaths)

Recalls

Facilities

Description

Closed Cell Self-Expanding Stent

Recalls

Date	Firm	Reason
2026-06-29	Contego Medical, Inc	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 followi
2026-05-01	INSPIREMD Inc	Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
2026-05-01	INSPIREMD Inc	Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
2026-05-01	INSPIREMD Inc	Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
2026-05-01	INSPIREMD Inc	Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
2026-05-01	INSPIREMD Inc	Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
2026-05-01	INSPIREMD Inc	Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
2025-09-04	Contego Medical LLC	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 a
2025-07-07	Boston Scientific Corporation	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 ste
2021-02-11	Cordis Corporation	Distal tip may become separated from the lumen wire in specific lots.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.