FDA-Device2023-09-06Class I
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Datascope Corp.
Hazard
Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
Sold states
Worldwide - US Nationwide distribution.
Affected count
9175 units
Manufactured in
1300 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 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-2432-2023Don't want to check this manually?
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