Defective products – AndraTec catheters
Defective products – AndraTec AltoSA-XL-Gemini balloon catheters
On 20 February 2024, AndraTec GmbH issued a safety notice regarding AltoSa-XL-Gemini balloon catheters, which are indicated for dilation of blood-vessel stenoses.
Certain batches of these products were stolen before they were sterilised, and may be offered for sale illegally by unauthorised third parties.
Action to take
The defective products should not be used.
If you possess any of these products, or if you see them on the market, please immediately contact the medical device market surveillance authority i.e. the Division of Pharmacy and Medicines (Division de la pharmacie et des médicaments) of the Health Directorate, at meddevices@ms.etat.lu.
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