NA EC300 (UDI 00613994384089)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994384089), received between Jan 12, 2018 and Jan 12, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Self-Activation or Keying” (1 report).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K081277); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 23, 2021Terminated

   Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.

   Z-1564-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2018Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THE HANDPIECE STALLED, THEN OPERATED AT LOW RPM WHEN THE FOOT SWITCH WAS NOT PRESSED. THE CONSOLE (EC300) WAS USED WITH THE FOOT SWITCH (1898430) WHEN THE EVENT OCCURRED. THERE WAS NO PATIENT IMPACT. REPORT 2 OF 2 - CONSOLE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7187571 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081277. One submission often covers many models, so check the product and lot details in each record.

• Z-0961-2022 · Dec 15, 2021 · Terminated
  Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E