medical Class I Updated 2019-07-24

Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-

Recalled Product

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.


Hazard / Issue

Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall.

Issued by

FDA

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

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