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

Recalled September 6, 2023 · FDA recall Z-2438-2023 · 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 Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Manufacturer(s)

Datascope Corp.

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