Agency classClass IIOur severity:High FDA (Devices)·Z-0537-2022·Announced 2022-02-09

DIXI Medical Microdeep Depth Electrode Packaging Defect Threatens Sterile Barrier

DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential packaging deformation that could compromise the sterile barrier. Approximately 2,720 units were distributed nationwide for use in brain recording and stimulation procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device with no reported illnesses or injuries. The potential for compromised sterility on a medical device used in brain procedures qualifies as a risk-of-harm product where injury has not yet been reported, per the severity rubric.

Plain-English summary

DIXI MEDICAL USA is recalling the Microdeep Depth Electrode, a medical device used for temporary recording, monitoring, and stimulation of electrical brain signals. The electrode is 0.8 mm in diameter with a rounded tip and contains platinum/iridium contacts. Approximately 2,720 units were distributed nationwide.

The recall was issued because the internal packaging (blister pack) of the device can potentially deform when removed from the outer Tyvek bag. This deformation could compromise the sterile barrier of the electrode, which is critical for maintaining the device's safety during minimally invasive brain procedures.

Healthcare facilities that have received these electrodes should stop using them and contact DIXI MEDICAL USA for further instructions on product replacement or return. Patients who may have received this device should consult with their healthcare provider if they have concerns about potential safety issues.

The recalled product

Product: 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…
Manufacturer: DIXI MEDICAL USA
Category: Medical Device — Surgical / Neurological
Hazard: packaging-defect
sterility-compromise
Affected units: 2,720

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lots UDI: 03664539000077

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by DIXI MEDICAL USA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · DIXI MEDICAL USA

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DIXI Microdeep Depth Electrodes recalled for potential packaging deformation compromising sterility
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Same hazard · packaging defect