Datascope Corp. is recalling approximately 11,517 Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps to provide an updated Instructions for Use (IFU) addendum. This update corrects the Vibration and Shock Table to reference the proper industry standards. The recall is administrative in nature and involves providing clinical users with the correct documentation rather than requiring the return of the physical medical devices.
The correction ensures that device documentation accurately reflects the vibration and shock testing standards the equipment meets. There are no reported injuries or device malfunctions associated with this documentation error.
Quantity: 11,470 units (5095 US, 6375 OUS)
Quantity: 47 units (44 US, 3 OUS)
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Sources: FDA iRES · Raw API Response
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