The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smoo...
FDA Recall #Z-0537-2022 — Class II — December 9, 2021
Product Description
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.
Reason for Recall
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Recalling Firm
DIXI MEDICAL USA — Plymouth, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2720 units
Distribution
US Nationwide distribution.
Code Information
All lots UDI: 03664539000077
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.