Field Safety Notices about Zelos PTA-balloon catheter

According to Swedish Medical Products Agency, this field safety notices involved a device in Sweden that was produced by OptiMed Medizinische Instrumente GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

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