Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, ...



Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist device intended to provide counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Components:
Units Affected:    471
Recall Date:    May 28, 2019
Mfg:
Datascope Corporation
Mfg Country:
United States
Recall ID:    83022
Product ID:    173345
Enforcement Date:    Jul 24, 2019
Last Published:    Jul 12, 2019

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Emert Number:    Z-1966-2019
Emert Status:    Announced