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Endovenous Radiofrequency Ablation (RFA) Catheter

Vein360 LLC · Model VEN-7-60 · UDI-DI 00860036000548

NUJGEI Prescription
10
510(k) clearances
773
Adverse events (2 deaths)
20
Recalls
22
Facilities

Description

Endovenous Radiofrequency Ablation (RFA) Catheter 7-60

Recalls

DateFirmReason
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge

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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.