Venclose™ EVSRF™ Catheter VC-10A2.5-6F-100 [10X]Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00858254006190), received between Feb 7, 2019 and Feb 7, 2019 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (K160754); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A ROUTINE ENDOVENOUS RADIOFREQUENCY ABLATION PROCEDURE OF THE GREATER SAPHENOUS VEIN (GSV) LOCATED ON THE LEFT LEG. DURING THE PROCEDURE A SKIN BURN OCCURRED AT THE ACCESS SITE BELOW THE LEFT KNEE, BUT THE SKIN BURN WAS NOT SEEN BY THE PHYSICIAN UNTIL THE FOLLOW-UP APPOINTMENT. THE DATE OF THE FOLLOW-UP APPOINTMENT IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES AND PATIENT IS DOING WELL. THE PATIENT WAS GIVEN BURN SALVE AT FOLLOW-UP APPOINTMENT. NO OTHER TREATMENT OR MEDICATION WAS GIVEN TO THE PATIENT. THE CLINIC INDICATED THAT THE DEVICE DID NOT MALFUNCTION DURING THE PROCEDURE THEREFORE, THE DEVICE WAS DISCARDED AFTER THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 8313952 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A ROUTINE ENDOVENOUS RADIOFREQUENCY ABLATION PROCEDURE OF THE GREATER SAPHENOUS VEIN (GSV) LOCATED ON THE RIGHT LEG. DURING THE PROCEDURE A SKIN BURN OCCURRED BELOW THE RIGHT KNEE, BUT THE SKIN BURN WAS NOT SEEN BY THE PHYSICIAN UNTIL THE FOLLOW-UP APPOINTMENT. THE DATE OF THE FOLLOW-UP APPOINTMENT IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES AND PATIENT IS DOING WELL. THE PATIENT WAS GIVEN BURN SALVE AT FOLLOW-UP APPOINTMENT. NO OTHER TREATMENT OR MEDICATION WAS GIVEN TO THE PATIENT. THE CLINIC INDICATED THE DEVICE DID NOT MALFUNCTION DURING THE PROCEDURE THEREFORE, THE DEVICE WAS DISCARDED AFTER THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 8313920 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160754. One submission often covers many models, so check the product and lot details in each record.

• Z-2638-2025 · Aug 21, 2025 · Open, Classified
  Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiR
• Z-0371-2025 · Sep 4, 2024 · Open, Classified
  The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to perma