November 5, 2019
FDA: Class I recall of Abbott CentriMag Circulatory Support System
Editor's Note
The Food and Drug Administration on November 4 identified the recall by Abbott of its CentriMag Circulatory Support System as Class I, the most serious.
The recall was initiated because of a calibration system error resulting from electromagnetic interference that may cause the pump to slow or stop, the console screen to blank, and various inaccurate alarms.
As of August 2019, 44 injuries and one death had been reported.
Distribution dates were November 22, 2017, to August 6, 2019.
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