Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 099

Recalled September 6, 2023 · FDA recall Z-2434-2023 · Datascope

Hazard

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

Units

47 units (42 US, 5 OUS)

Sold at

Worldwide - US Nationwide distribution.

Description

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

Product

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,

Manufacturer(s)

Datascope Corp.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →