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FDAJuly 17, 2017device

CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes mor...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.

What to do

FDA enforcement status: Ongoing

Brands named

maquet datascope corp cardiac assist divisionmaquetmaquet datascope

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes mor... — Recall Details · AllClear