National Directorate of Medicines, Food and Medical Technologies (AnMAT) ordered the ban on the use, commercialization and distribution of the medical product used to evaluate the electrical activity of the brain.
The measure, published in the official newspaper through position 4622/2025, affects several units of the monopolar insert – the ATI electrodes usually used on electroencephalograms to detect epileptogenic foci or determine the death of the brain.
Why was this decision made?
The investigation occurred after a series of inspections conducted in Surgic Implats based in the city of Cordoba.
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During the procedure, AnMat employees found seven units of the product in irregular conditions packaged in bags without significant information, such as the lot number, date of expiration, manufacturer or identification case.
Faced with the lack of documentation, the company presented a few days later the invoice, released by Advantek Srl, living in the city of Buenos -Aires. Anmat also checked this headquarters and found that the electrodes were not registered in the company’s systems.
The head of the company recognized that they were sometimes produced and distributed without compliance with regulatory requirements.
Risk and sanctions
As described in detail in the official position, these electrodes are part of the high -risk system (classification IV) in order to be designed for the diagnosis and treatment of complex diseases of the brain. Without compulsory health control, they represent a risk for patients and medical workers.
For this reason, Anmat ordered a complete interruption of the use and marketing of the product until its situation is streamlined. The sample for analysis was taken, and the remaining six units found in the institution were inhibited.
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In addition, healthcare resumes began to participate in both companies. Surgic Implands SA was indicated by the alleged violations available for disposal 6052/2013 and the Law 16 463, while Adevantek SRL was reached by the position of 64/25 and the same national legislation.
ANMAT Warning
Anmat confirmed that the production and distribution of unauthorized medical products is prohibited, and that each device should have sanitary records, tracking and official resolution.
In this case, the agency also notified the provincial authorities of Córdoba and the Ministry of Local Health to guarantee the cancellation of the market for irregular products.
