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.
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 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…
- Manufacturer
- DIXI MEDICAL USA
- Affected units
- 345
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.
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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