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LUTONIX® Drug Coated Balloon

LUTONIX, INC. · Model LX181505605F · UDI-DI 00801741199271

PRCONU Prescription
0
510(k) clearances
525
Adverse events (8 deaths)
1
Recalls
8
Facilities

Description

Lutonix 018 5X60MMX150CM

Recalls

DateFirmReason
2022-03-23Medtronic Vascular, Inc.Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.