Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099

Recalled September 6, 2023 · FDA recall Z-2437-2023 · Datascope

Hazard

Users were identifying autofill failure conditions on the devices causing pump stops. · FDA Class I

Units

9175 units

Sold at

Worldwide - US Nationwide distribution.

Description

Users were identifying autofill failure conditions on the devices causing pump stops.

Product

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65

Manufacturer(s)

Datascope Corp.

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