FDA DevicesClass III
Battery Charging Station; Model: 0998-00-0802;
Published: March 25, 2026Recall ID: Z-1587-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Battery Charging Station; Model: 0998-00-0802;
Affected Products
Battery Charging Station; Model: 0998-00-0802;
Additional Source Details
| Field | Value |
|---|---|
| City | Mahwah |
| State | NJ |
| Event id | 98432 |
| Address 1 | 1300 Macarthur Blvd |
| Address 2 | N/A |
| Code info | Model: 0998-00-0802; UDI: 10607567111964; Serial Numbers: 200019347EAI, 200019847EAI, 200019447EAI, 210018625EAI, 210017925EAI, 210017525EAI, 210018425EAI, 210020144EAI, 210020944EAI, 210022544EAI, 210020244EAI, 210022144EAI, 210020044EAI, 210020544EAI, 210021344EAI, 210023244EAI, 210018025EAI, 210019025EAI, 210021144EAI, 210021044EAI, 210022344EAI, 210019225EAI, 210019125EAI, 210018525EAI, 210022844EAI, 200017647EAI, 210019725EAI, 210022744EAI; |
| Postal code | 07430-2052 |
| Report date | 20260325 |
| Product type | Devices |
| Product quantity | 28 units (20 US, 8 OUS) |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260206 |
| Initial firm notification | Letter |
| Center classification date | 20260319 |
Overview
- Recalling FirmDatascope Corp.
- StatusOngoing
- Risk LevelClass III
- DistributionWorldwide - 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.