DIXI Medical Depth Electrodes recalled for potential sterile packaging defect
DIXI MEDICAL USA is recalling 461 Microdeep Depth Electrodes. The internal blister packaging may deform, potentially compromising the sterile barrier when removed from the protective Tyvek bag.
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 risk-of-harm medical device (brain electrode) with a potential defect affecting sterility. Although no injuries have been reported, the potential for sterile barrier compromise on a high-risk implantable device warrants High severity per the rubric.
Plain-English summary
The DIXI Medical Microdeep Depth Electrode is a 0.8 mm brain electrode used for recording, monitoring, and stimulating electrical signals in the brain. The recall affects 461 units distributed nationwide in the United States.
The internal blister packaging may deform, potentially compromising the device's sterile barrier when removed from the protective Tyvek bag.
Consumers and medical facilities should discontinue use of affected electrodes. All units with UDI 03664539000152 are included in the recall. Contact DIXI MEDICAL USA for instructions regarding return, replacement, or disposal.
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
- Affected units
- 461
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:03664539000152
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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