FDA-Device2018-04-25Class II
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.
Datascope Corporation
Hazard
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Sold states
US Nationwide Distribution
Affected count
2714
Manufactured in
15 Law Dr, Fairfield, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1383-2018Don't want to check this manually?
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