FDAFebruary 6, 2026device
Battery Charging Station; Model: 0998-00-0802;
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
datascope
UPCs
10607567111964
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACS300 IABP. Software Version CS300 IABP C.01.2026-01-23
- FDACS100 IABP. Software Version CS100 IABP Q.01.2026-01-23
- FDACardiosave Rescue. Intra-Aortic Balloon Pump system.2025-11-04
- FDACardiosave Hybrid. Intra-Aortic Balloon Pump system.2025-11-04
- FDACardiosave Rescue2025-10-23
- FDACardiosave Hybrid2025-10-23
- FDAMEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-012024-09-17
- FDACARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.2024-08-08
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