medical Class II Updated 2021-10-06

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

Recalled 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

Hazard / Issue

The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.

Issued by

FDA

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

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