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Maquet Datascope Corp - Cardiac Assist Division recalls Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Recalled November 7, 2018 · FDA recall Z-0099-2019 · Maquet Datascope Corp - Cardiac Assist Division
Hazard
There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft. · FDA Class I
Units
N/A
Sold at
US Nationwide; Internationally to 77 countries
Description
There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
Product
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Manufacturer(s)
Maquet Datascope Corp - Cardiac Assist Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →