Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-0

Recalled October 13, 2021 · FDA recall Z-0075-2022 · Datascope

Hazard

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference. · FDA Class II

Units

5054 total (US), 5033 total (OUS)

Sold at

Worldwide distribution - US Nationwide distribution.

Description

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

Product

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

Manufacturer(s)

Datascope Corp.

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