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Maquet Datascope Corp - Cardiac Assist Division recalls Cardiosave Hybrid and rescue IABP
Recalled April 6, 2016 · FDA recall Z-1248-2016 · 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. · FDA Class II
Units
1243 units US; 1107 units OUS
Sold at
Worldwide Distribution- Nationwide Distribution including Puerto Rico.
Description
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.
Product
Cardiosave Hybrid and rescue IABP
Manufacturer(s)
Maquet Datascope Corp - Cardiac Assist Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →