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LUTONIX ® 035 Drug Coated Balloon PTA Catheter
LUTONIX, INC. · Model LX351001220V · UDI-DI 00801741135781
PRC
Prescription
0
510(k) clearances
525
Adverse events (8 deaths)
1
Recalls
8
Facilities
Description
Lutonix® AV Drug Coated Balloon PTA Catheter 12x20x100
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-23 | Medtronic Vascular, Inc. | Packaging for Balloon Catheters may be damaged resulting in loss of sterility. |
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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.