Agency classClass IIOur severity:High FDA (Devices)·Z-0539-2022·Announced 2022-02-09

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.

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 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…
Manufacturer: DIXI MEDICAL USA
Category: Medical Device — Surgical / Neurological Electrode
Hazard: sterile-barrier-compromise
contamination-risk
packaging-defect
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 →

Same manufacturer · DIXI MEDICAL USA

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DIXI Medical Microdeep Depth Electrode Packaging Defect Threatens Sterile Barrier
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DIXI Microdeep Depth Electrode packaging deformation poses sterility risk
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DIXI Microdeep Depth Electrode sterile barrier packaging defect
FDA (Devices) · 2022-02-09
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Microdeep Depth Brain Electrodes recall due to sterile barrier compromise risk
FDA (Devices) · 2022-02-09
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DIXI Microdeep Depth Electrodes recalled for potential packaging deformation compromising sterility
FDA (Devices) · 2022-02-09

Same hazard · sterile barrier compromise