FDA recall Z-1587-2026

Datascope Corp. · Class III · device

Product

Battery Charging Station; Model: 0998-00-0802;

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.

Key facts

Status
Ongoing
Initiation date
2026-02-06
Report date
2026-03-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1587-2026