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Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Recalled June 21, 2023 · FDA recall Z-1907-2023 · Datascope
Hazard
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. · FDA Class III
Units
4 units
Sold at
International distribution in the country of Germany.
Description
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Manufacturer(s)
Datascope Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →