DIXI MEDICAL USA recalls The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0…

Recall date

December 9, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0536-2022

FDA classification

Class II

Brand / firm

DIXI MEDICAL USA

Sold / distributed

US Nationwide distribution.

Why it was recalled

Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.