Official recall notice
FDA Recall: Battery Charging Station; Model: 0998-00-0802;
- Recall date
- 2026-03-25
- Brand
- Datascope Corp.
- Category
- Medical Device
- FDA class
- Class III
Why it was recalled
Hazard
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.
Recommended action
What to do
28 units (20 US, 8 OUS)
Product description
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.