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OnyxTM Liquid Embolic System (LES)
Micro Therapeutics, Inc. · Model 105-7100-080 · UDI-DI 00763000925352
MFE
Prescription
0
510(k) clearances
3,062
Adverse events (259 deaths)
2
Recalls
3
Facilities
Description
LIQUID EMBOLIC 105-7100-080 V08
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-11 | Micro Therapeutics, Inc. | European version of microcatheter were distributed within US which contain a different "Indications for Use". |
| 2024-01-11 | Micro Therapeutics, Inc. | European version of microcatheter were distributed within US which contain a different "Indications for Use". |
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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.