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One Death Linked To Calyxo Urological System

 
• By Brian Bossetta

The US FDA has issued an early alert about the CVAC system from Calyxo, which urologists use in removing urinary stones.

(Shutterstock)

The US FDA has reported one death associated with the CVAC aspiration system and CVAC image processor from Calyxo, which are used to establish a channel during endoscopic urological procedures to treat and remove urinary stones.

The alert is part of the FDA’s ongoing pilot to improve its recall process by sending out advanced warnings on corrective actions the agency believes will...

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