Datascope Corp.

Datascope's Battery Charging Station (Model 0998-00-0802) for Cardiosave IABP batteries has a protruding screw in the left bay that can prevent certain batteries from inserting fully and charging properly. The right bay works normally. This affects 28 units distributed in select U.S. states and international locations.

Datascope Corp. has identified that the battery runtime and cycle specifications in the instruction manual for the CS300 IABP (intra-aortic balloon pump) device need to be corrected. The device itself is safe to use, but the written specifications may not accurately reflect actual battery performance.

Datascope Corp. identified that the battery runtime and cycle specifications in the instruction manual for the CS100 IABP (intra-aortic balloon pump) device are incorrect and need to be updated. The device itself is not defective, but users may rely on outdated battery information.

Datascope Corp. has issued an updated instruction manual (IFU) for the Cardiosave Rescue defibrillator. The update corrects references in the Vibration and Shock Table to match the proper technical standards. This affects 47 units distributed in the US and internationally.

Datascope Corp. is updating the instruction manual for Cardiosave Hybrid devices to correct references in the Vibration and Shock Table to ensure alignment with applicable standards. This is a documentation correction that affects multiple device models.

Datascope Corp. is updating the maintenance schedule for Cardiosave Rescue intra-aortic balloon pump systems to match changes made to the Service Manual in June 2023. This affects 47 units distributed worldwide. No injuries have been reported.

Datascope Corp. has updated the preventative maintenance schedule for Cardiosave Hybrid intra-aortic balloon pump systems to match changes made to the Service Manual in June 2023. Users should review the updated Instructions for Use (IFU) addendum to ensure proper maintenance timing.