FDA-Device2015-03-04Class II
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Maquet Datascope Corp - Cardiac Assist Division
Hazard
Power supply malfunction complaints related to suboptimal thermal management.
Sold states
US Nationwide distribution
Affected count
1,300 units
Manufactured in
1300 MacArthur Blvd., N/A, Mahwah, NJ, United States
Products
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1140-2015Don't want to check this manually?
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