This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate Class I recall earlier this month. The company also initiated recall that the FDA determined was Class I in December 2021.
In 2021, the company recalled the systems because fluid entry could cause unexpected pump shutdown or the inability to initiate therapy. The recall earlier this month centered around the potential failure of the coiled cable connecting the display and base.
FDA’s notice today said the latest recall comes as a result of a potential communication loss.
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