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Endovenous Radiofrequency Ablation (RFA) Catheter
Vein360 LLC · Model VEN-7-100 · UDI-DI 08600360005008
10
510(k) clearances
773
Adverse events (2 deaths)
20
Recalls
22
Facilities
Description
Endovenous Radiofrequency Ablation (RFA) Catheter 7-100
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-01 | Medline Industries, LP | Medline 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 |
| 2025-10-01 | Medline Industries, LP | Medline 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 |
| 2025-10-01 | Medline Industries, LP | Medline 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 |
| 2025-10-01 | Medline Industries, LP | Medline 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 |
| 2025-10-01 | Medline Industries, LP | Medline 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 |
| 2025-10-01 | Medline Industries, LP | Medline 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 |
| 2025-10-01 | Medline Industries, LP | Medline 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 |
| 2025-10-01 | Medline Industries, LP | Medline 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 |
| 2025-10-01 | Medline Industries, LP | Medline 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 |
| 2025-10-01 | Medline Industries, LP | Medline 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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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.