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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On June 17, 2019, the firm notified its customers of the product issue via Urgent Medical Device Correction letters. Customers are to take the following immediate interim actions: " Ensure the IABP is plugged into an AC power outlet whenever possible during patient use to prevent the battery from depleting. " Ensure the IABP is plugged into an AC power outlet when the system is not in use. The batteries should be kept at a full charge even when the IABP is not in use. " When transporting patients within or between facilities, please refer to the IABP Operating Instructions Manual for recommendations on portable/battery operation. For example: " Prior to portable operation, the battery should be fully charged " For Cardiosave Rescue and Cardiosave Hybrid only: " Additional charged batteries should be on hand during transport " Ensure the batteries are properly seated in the battery compartment/charger and the IABP Console is completely seated/secured into the IABP Cart " For Cardiosave Hybrid, you can verify if the Console is completely seated in the IABP cart by the indicator on the display. Check battery run time and replace batteries as required, as recommended in each IABPs Operating Instructions Manual. A reduction in run time can occur over a battery's life for reasons such as age, storage temperature and discharge depth. Batteries should be replaced: " After reaching the maximum number of charge-discharge cycles " When the battery provides less than the minimum specified run time " If the battery is broken, cracked, leaking or damaged " When the labeled lifetime of the battery is reached NOTE: Batteries for the Cardiosave Hybrid and Cardiosave Rescue IABPs sold before June 2015 should be replaced immediately as the labeled lifetime for these batteries is 4 years. Replacement batteries can be ordered through your sales or service representative. To determine the date of manufacture for all Cardiosave batteries, refer to attached d