FDA-Device2021-10-13Class II
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Datascope Corp.
Hazard
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
Sold states
Worldwide distribution - US Nationwide distribution.
Affected count
5054 total (US); 5033 total (OUS)
Manufactured in
1300 Macarthur Blvd, Mahwah, NJ, United States
Products
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0076-2022Don't want to check this manually?
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