DIXI Microdeep Depth Electrode sterile barrier packaging defect
DIXI Medical Microdeep Depth Electrodes are recalled due to potential deformation of the blister pack packaging that could compromise the sterile barrier. 345 units nationwide are affected.
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 Class II medical device where potential deformation of sterile packaging could compromise the barrier protecting a brain electrode, a critical-use application. However, no reported illnesses or injuries have occurred, limiting the score per the rubric for theoretical hazards.
Plain-English summary
The DIXI Medical Microdeep Depth Electrode is a medical device used to record, monitor, and stimulate electrical signals from subsurface areas of the brain during clinical procedures. It contains platinum/iridium contacts and is intended for temporary use.
The recall is issued because the blister pack (internal packaging) could become deformed when removed from the outer Tyvek bag. This deformation could compromise the sterile barrier that protects the electrode.
This recall affects 345 units identified by UDI 03664539000114 that were distributed nationwide in the United States. The device is classified as a Class II medical device by the FDA.
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
- sterile-barrier-compromise
- contamination-risk
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:03664539000114
Distribution
Distributed nationwide across the United States.
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