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Potential Pump Malfunction Results In Class I Recall For LifeSPARC Circulatory System

 
• By Brian Bossetta

The US FDA has labelled a recall of several hundred components of the LifeSPARC circulatory support system from LivaNova as class I, the agency’s most serious recall designation.

Handwriting text showing Product Recall.
• Source: Alamy

LivaNova has recalled its LifeSPARC controller, which is a part of the LifeSPARC circulatory support system used to sustain patients during open heart surgeries.

The system has two components – the controller and a single-use pump. The controller pumps blood through an extracorporeal circuit during full or partial cardiopulmonary bypass, or to divert blood...

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