Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Recalled October 13, 2021 · FDA recall Z-0076-2022 · 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 Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 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 →