Death and injuries reported amid Abbott’s recall of CentriMag circulatory support system

The U.S. FDA today issued a Class I designation — its most serious — over Abbott’s recall of its CentriMag circulatory support system.

By the time Abbott (NYSE:ABT) initiated a recall in August 2019, there were already reports of one death and 44 injuries related to electromagnetic interference problems with the system console, according to FDA.

The system, which has roots in Levitronix and Thoratec technology, is similar to an LVAD in that it’s a pump providing temporary heart support. It can pump blood through a person undergoing an open-heart procedure, but it can also provide temporary blood circulatory support for up to 30 days to treat cardiogenic shock.

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