DIXI Medical Microdeep Depth Electrode Sterile Barrier Compromise Recall
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes used in neurological monitoring and stimulation due to potential deformation of the internal sterile packaging. The compromised sterile barrier could allow contamination before use.
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 surgical device where potential sterile barrier compromise creates contamination risk, but no illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
DIXI MEDICAL USA is recalling the Microdeep Depth Electrode, a neurosurgical device used for recording, monitoring, and electrical stimulation of brain signals at subsurface levels. All lots with UDI 03664539000039 are included in the recall, affecting 1,894 units distributed nationwide.
The recall was initiated due to potential deformation of the internal blister pack packaging. This deformation could compromise the sterile barrier of the device when removed from its outer protective Tyvek bag, potentially allowing contamination before use.
Healthcare facilities that have received Microdeep Depth Electrodes should stop use and contact DIXI MEDICAL USA for instructions regarding affected inventory. The FDA classified this as a Class II 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: 03664539000039
Distribution
Distributed nationwide across the United States.
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