ANMAT prohibits three stolen Gore VBX endoprostheses that are outside of traceability

The National Administration of Drugs, Foods and Medical Devices (ANMAT) has prohibited the use, marketing, advertising, and distribution throughout the national territory of three units of the Gore VIABAHN VBX endoprosthesis that lost traceability following a theft. The decision was adopted through Provision 7199/2026 (DI-2026-7199-APN-ANMAT#MS), signed on November 4, 2026, by the national administrator Luis Eduardo Fontana and published in the Official Gazette of the Argentine Republic on November 11, 2026.

Case file EX-2026-60377798-APN-DGA#ANMAT was initiated when the Directorate of Evaluation and Management of Health Product Monitoring received a communication regarding the theft of medical products identified as “VIABAHN BX GORE® VIABAHN® brand,” registered with the agency under the ownership of the firm Emeclar S.A. The items are authorized under Medical Product Certificate PM 266-82, indicated for the “treatment of new or restenotic lesions located in the iliac arteries of specific diameters, including lesions in the aortic bifurcation.”

According to police report PP-18-01-005821-26/00, the incident occurred on June 12, 2026, during courier duties: the operator left the box containing the items intended for the day’s deliveries on a chair and, upon returning to the site, found that they had been stolen.

The three affected units

The prohibition applies to three units of the “Gore VIABAHN VBX balloon-expandable endoprosthesis,” one for each presentation, all of the GORE® VIABAHN® brand and with registration PM 266-82:

• Code/Reference BXA055902H, serial and lot number 28350476, expiration 02/02/2027.
• Code/Reference BXA053902H, serial and lot number 29004355A, expiration 05/05/2027.
• Code/Reference BXA053902H, serial and lot number 29004356A, expiration 05/05/2027.

The official text notes an internal difference in identification: the preamble describes one unit of model VBX5X59, lot 28359476, and two of model VBX 5X39, lots 29004355 A and 29004356 A, while Article 1 identifies the serial and lot numbers as 28350476, 29004355A, and 29004356A.

Products outside the owner’s control

The basis for the measure is that the condition and state of preservation of the products are unknown, as they “have fallen outside the control and traceability of the owning firm.” For this reason, the agency considered a sanitary prohibition measure appropriate, aimed at “protecting potential purchasers and users of the involved products.”

The scope is not limited to traditional channels: it also includes publication and offering on electronic sales platforms. The provision is based on subsection ñ) of Article 8 of Decree No. 1,490/92, which empowers the agency to adopt preventive and corrective measures when it detects risk factors linked to the quality and safety of the products under its jurisdiction, and on Law No. 16,463. The Legal Affairs Directorate and the Summary Proceedings Coordination also intervened.

Challenge deadlines and notifications

Article 2 establishes that the provision exhausts the administrative route and sets the deadlines to challenge it, computed from the day following the notification:

• Request for reconsideration: 20 administrative business days.
• Appeal to a higher authority (Recurso de alzada): 30 administrative business days.
• Judicial action: 180 judicial business days.

Article 3 orders the measure to be communicated to the jurisdictional health authorities, the National Directorate of Regulatory Management and Control of the Undersecretariat for Consumer Defense and Fair Trade of the Secretariat of Industry and Commerce of the Ministry of Economy, the Directorate of Evaluation and Monitoring Management of Health Products, the Directorate of Technical Information Management, and the Summary Proceedings Coordination.

The relevance of the measure is twofold: on one hand, it removes high-cost vascular devices from the commercial circuit whose state of preservation cannot be guaranteed; on the other, it exposes a critical link in the distribution chain of medical products, where the loss of traceability during transport is sufficient to trigger a national prohibition that reaches hospitals, distributors, and online sales platforms.

Source: Official Gazette of the Argentine Republic, First Section, November 11, 2026 (official reference: notice 350205, Provision 7199/2026 — DI-2026-7199-APN-ANMAT#MS).