FDAJune 5, 2023device
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
What to do
FDA enforcement status: Ongoing
Brands named
datascope
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABattery Charging Station; Model: 0998-00-0802;2026-02-06
- FDACS300 IABP. Software Version CS300 IABP C.01.2026-01-23
- FDACS100 IABP. Software Version CS100 IABP Q.01.2026-01-23
- FDACardiosave Hybrid. Intra-Aortic Balloon Pump system.2025-11-04
- FDACardiosave Rescue. Intra-Aortic Balloon Pump system.2025-11-04
- FDACardiosave Hybrid2025-10-23
- FDACardiosave Rescue2025-10-23
- FDAMEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-012024-09-17
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