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XACT™
ABBOTT VASCULAR INC. · Model 82093-01 · UDI-DI 08717648010293
NIM
Prescription
0
510(k) clearances
8,649
Adverse events (695 deaths)
25
Recalls
25
Facilities
Description
XACT™ Carotid Stent System 8.0 mm x 20 mm Straight
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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Get your free API keyRead the docsData 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.