Agency classClass IIOur severity:High FDA (Devices)·Z-0541-2022·Announced 2022-02-09

DIXI Microdeep Depth Electrodes recalled for potential packaging deformation compromising sterility

DIXI MEDICAL USA is recalling 1792 Microdeep Depth Electrodes due to potential deformation of the internal blister pack that could compromise the sterile barrier when the device is removed from its 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 Class II medical device with a potential risk-of-harm due to sterility barrier compromise. No illnesses or injuries have been reported, but the hazard is theoretical and could result in infection if non-sterile equipment is used in brain tissue insertion. Per the rubric, risk-of-harm products without reported injury score as High.

Plain-English summary

DIXI MEDICAL USA is recalling 1792 Microdeep Depth Electrodes (all lots, UDI: 03664539000176). The Microdeep Depth Electrode is a thin electrode 0.8 mm in diameter with platinum/iridium contacts intended for temporary use with recording and monitoring equipment to detect, monitor, and stimulate electrical signals in brain tissue during neurosurgical procedures.

The recall was issued because the internal packaging (blister pack) may be deformed in a way that compromises the sterile barrier of the device when removed from the Tyvek outer bag. A compromised sterile barrier could lead to contamination of the electrode and increase the risk of infection when inserted into brain tissue.

If you possess or use this product, do not use affected units and contact DIXI MEDICAL USA immediately. The recall affects all lots with UDI 03664539000176 and applies to all units distributed nationwide in the United States.

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 — Neuroelectrode
Hazard: sterility-barrier-compromise
packaging-defect
contamination-risk
Affected units: 1,792

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:03664539000176

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

See all →

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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 Medical Depth Electrodes recalled for potential sterile packaging defect
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DIXI Microdeep Depth Electrode sterile barrier packaging defect
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Microdeep Depth Brain Electrodes recall due to sterile barrier compromise risk
FDA (Devices) · 2022-02-09

Same hazard · sterility barrier compromise