Microdeep Depth Brain Electrodes recall due to sterile barrier compromise risk
DIXI Medical is recalling 484 Microdeep Depth Electrodes nationwide due to potential deformation of internal packaging that could compromise the sterile barrier of these brain recording devices.
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 recall involving potential compromise of sterile barrier on a medical device used in brain procedures. The hazard is theoretical (potential deformation leading to contamination risk) with no reported illnesses or injuries in the source, meeting the criterion for High severity as a risk-of-harm product without confirmed injury.
Plain-English summary
DIXI Medical USA is recalling 484 Microdeep Depth Electrodes distributed nationwide. The Microdeep Depth Electrode is a 0.8 mm diameter electrode with platinum/iridium contacts, intended for temporary use with brain recording, monitoring, and stimulation equipment used to record electrical signals in the brain.
The recall was initiated because potential deformation of the internal blister pack packaging could compromise the sterile barrier of the device. When the electrode is removed from its outer Tyvek bag, a deformed inner package may fail to maintain sterile conditions, potentially exposing the device to contamination.
Healthcare providers and facilities who have received these devices should contact DIXI Medical USA regarding the recall.
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: 03664539000015
Distribution
Distributed nationwide across the United States.
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