FDAFebruary 7, 2023device
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
What to do
FDA enforcement status: Ongoing
Brands named
datascope
UPCs
09980008008310607567108407
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
- FDACS100 IABP. Software Version CS100 IABP Q.01.2026-01-23
- FDACS300 IABP. Software Version CS300 IABP C.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 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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