Class III

Medical Device Recall: Battery Charging Station; Model: 0998-00-0802;

Datascope Corp. · February 6, 2026

Reason for Recall

The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.

Distribution

Worldwide - US Nationwide distribution in the states of FL, DC, GA, IL, IN, MD, MI, NC, TX, WA, WI and the countries of Australia, Hong Kong, Israel, Japan, Norway.

States Affected

NATIONWIDE

Quantity Affected

28 units (20 US, 8 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1587-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.