Venclose Maven Catheter VC056FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00858254006398), received between May 24, 2024 and Nov 6, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K211806); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available; Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION PROCEDURE, THE CATHETER WAS ALLEGEDLY EXPIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20617322 ↗
• MalfunctionNov 5, 2024Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available; Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING RF ABLATION PROCEDURE, THE CATHETER USED HAD ALLEGEDLY EXPIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609843 ↗
• MalfunctionMay 24, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR A RADIOFREQUENCY ABLATION PROCEDURE, THE EXPIRATION DATE ON THE LABEL OF THE DEVICE WAS ALLEGEDLY MISMATCHING WITH THE EXPIRATION DATE LOADED IN THE ENTERPRISE RESOURCE PLANNING SYSTEM (JDE). THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19389864 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211806. 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