FDA Recalls DIXI Medical Microdeep Depth Electrodes Due to Packaging Defect
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes nationwide due to potential internal packaging deformation that could compromise the device's sterile barrier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with potential sterile-barrier compromise. While no illnesses or injuries have been reported, the device is used for invasive brain procedures, making it a risk-of-harm product where sterility is critical. The defect involves potential packaging deformation affecting this essential safety feature.
Plain-English summary
The FDA has issued a recall for the DIXI Medical Microdeep Depth Electrode manufactured by DIXI MEDICAL USA. The device is a small electrode approximately 0.8 mm in diameter with platinum/iridium contacts, designed for recording, monitoring, and stimulation of electrical signals at subsurface brain levels during medical procedures.
The recall affects approximately 3,548 units distributed nationwide. The recall was issued because potential deformation of the internal packaging (blister pack) could compromise the sterile barrier of the device when it is removed from its protective Tyvek bag. All lots with UDI 03664539000091 are affected by this recall.
No illnesses or injuries have been reported in connection with this defect.
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…
- Manufacturer
- DIXI MEDICAL USA
- Category
- Medical Device
- Affected units
- 3,548
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:03664539000091
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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