FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Abbott Pulls Blood Pump Over Risks of Slowing or Stopping

Nov. 6, 2019

Abbott has initiated a Class I recall of its CentriMag System, a device that pumps blood through a patient during open-heart surgeries, citing problems with its motor and pump.

The recall was prompted by a calibration system error caused by electromagnetic interference that could produce false alarms, console screen blanking and slowing or stopping of the pump.

Slowing or stopping of the pump puts the patient at risk of serious health risks, including stroke, severe organ damage and death. 44 injuries and one death were reported at the time of the recall, the FDA said.

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