medical Class II Updated 2021-10-13

Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model No

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots
View official government recall

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