medical Class II Updated 2018-04-25

Datascope Corporation recalls Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usa

Recalled Product

Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation 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.


Hazard / Issue

The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 0684 00 0295 01U and 0684 00 0295 02U
View official government recall

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