DIXI MEDICAL USA: Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag

Agency Publication Date: January 28, 2022

Affected Products

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 varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulati

All lots UDI: 03664539000015

All lots UDI: 03664539000039

All lots UDI: 03664539000053

All lots UDI: 03664539000077

All lots UDI:03664539000091

All lots UDI:03664539000152

All lots UDI:03664539000114

All lots UDI:03664539000176

All lots UDI:03664539000138

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89306

Status: Resolved

Manufacturer: DIXI MEDICAL USA

Manufactured In: United States

Units Affected: 9 products (484 units; 1894 units; 2141 units; 2720 units; 3548 units; 461 units; 345 units; 1792 units; 365 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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