DIXI Microdeep Depth Electrode packaging deformation poses sterility risk
DIXI Medical USA is recalling 2,141 Microdeep Depth Electrodes nationwide due to potential deformation of the blister pack that could compromise the sterile barrier when devices are removed from their Tyvek bags.
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: This is a risk-of-harm medical device (brain electrode with critical sterile barrier requirement) with no reported illnesses or injuries. The hazard is theoretical—potential deformation that could compromise sterility—making it a High severity recall per the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DIXI Medical USA is recalling 2,141 Microdeep Depth Electrodes distributed nationwide. The device is a smooth electrode 0.8 mm in diameter with a rounded tip and multiple platinum/iridium contacts, designed for temporary use in recording, monitoring, and stimulation of electrical signals in the brain.
The recall was issued because the internal packaging (blister pack) may deform, which could compromise the sterile barrier when the electrode is removed from its outer Tyvek bag. This potential sterility breach poses a risk to patient safety during neurosurgical procedures.
The recalled electrodes are identified by UDI 03664539000053 (all lots). The recall affects facilities and medical professionals using these electrodes for brain monitoring and stimulation procedures. Healthcare providers should identify and secure recalled units and contact DIXI Medical USA for further guidance on returns and replacement devices.
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
- Affected units
- 2,141
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: 03664539000053
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 →Related recalls
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