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LUTONIX® Drug Coated Balloon
LUTONIX, INC. · Model BSCLX351305150 · UDI-DI 00801741105012
OUR
Prescription
10
510(k) clearances
1,406
Adverse events (5 deaths)
1
Recalls
154
Facilities
Description
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x150mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
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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.