Datascope Corp. recalls
18 federal recalls on file, showing the 4 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Datascope Corp. and put it in plain English.
Recent recalls
Check your Datascope battery charger left bayDatascope'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.
FDAMar 25, 2026
- Check your Datascope CS100 IABP instructions
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 The device itself is not defective, but users may rely on outdated battery information.
ModerateFDAMar 11, 20262 products
- Datascope Cardiosave devices recalled for outdated shock standards
Datascope is recalling two Cardiosave devices, Cardiosave Hybrid and Cardiosave Rescue, which are included in this recall for about 11,517 units. The recall was issued because an instructions-for-use addendum updated the Vibration and Shock Table to reference the correct standards. No injuries have been reported.
FDADec 24, 20252 products
- Datascope Cardiosave pumps need updated maintenance schedule
Datascope is recalling two Cardiosave intra-aortic balloon pump systems, the Cardiosave Hybrid and the Cardiosave Rescue. The recall is for an addendum to the instructions for use that revises the preventative maintenance schedule to match the service manual update made in June 2023. No injuries have been reported.
ModerateFDADec 17, 20252 products