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.
What this means for you
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 va
- Manufacturer
- DIXI MEDICAL USA
- Hazard
- packaging-defect
- sterility-compromise
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.
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