FDA-Device2016-04-06Class II
Cardiosave Hybrid and rescue IABP
Maquet Datascope Corp - Cardiac Assist Division
Hazard
Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.
Sold states
Worldwide Distribution- Nationwide Distribution including Puerto Rico.
Affected count
1243 units US; 1107 units OUS
Manufactured in
1300 MacArthur Blvd., N/A, Mahwah, NJ, United States
Products
Cardiosave Hybrid and rescue IABP
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1248-2016Don't want to check this manually?
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