Datascope Corporation recalls Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used t…

Recall date

February 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1385-2018

FDA classification

Class II

Brand / firm

Datascope Corporation

Sold / distributed

US Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Intra-Aortic Balloon Catheter Mega 8FR 50cc 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.