FDA-Device2023-03-15Class II
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Datascope Corp.
Hazard
There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.
Sold states
US Nationwide. Global Distribution.
Affected count
8909 units
Manufactured in
1300 Macarthur Blvd, Mahwah, NJ, United States
Products
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1230-2023Don't want to check this manually?
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