Midas Rex® EC300RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169931459), received between Mar 7, 2025 and Mar 7, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K081475); 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.

• MalfunctionMar 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING SACROILIAC AND THORACOLUMBAR PROCEDURE, THE IPC SYSTEM SHOCKED THE SURGEON TWICE WHEN TOUCHED THE BONE; TRIED MULTIPLE HANDPIECES. THE DRILL WAS THE ONLY DEVICE BEING USE AT THE TIME. AS THE BURR WAS TOUCHING THE BONE, THE USER STEPPED ON THE PEDAL AND WAS SHOCKED. THERE WAS NOT ANY HARDWARE IN THE PATIENT AT THE TIME. SWITCHED OUT THE CONSOLE AND EVERYTHING WAS OK. NO FURTHER SHOCKING. THE SURGEON IS OK, HAD SOME NUMBNESS AND TINGLING FOR APPROXIMATELY 10 MINUTES. THERE WAS A PROCEDURAL DELAY OF LESS THAN AN HOUR AND NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21545230 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081475. 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
• Z-0158-2022 · Aug 31, 2021 · Open, Classified
  Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with
• Z-2085-2016 · May 13, 2016 · Terminated
  Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: