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, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,

Datascope Corp.

Hazard

Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

Sold states

Worldwide - US Nationwide distribution.

Affected count

47 units (42 US, 5 OUS)

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, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2434-2023

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