Model note · Intra-aortic Balloon Pump
Datascope Cardiosave Hybrid Intra-Aortic Balloon Pump
The Cardiosave Hybrid is an intra-aortic balloon pump that shuttles helium into and out of a balloon in the descending aorta, inflating at the dicrotic notch and deflating just before systole. It is used in cath labs, cardiac surgery and intensive care to raise coronary perfusion and cut left ventricular work. Its distinctive feature is that one pump console works on a hospital cart or lifted off for transport (Rescue configuration) on hot-swappable lithium-ion batteries.
The model
Maker, model and type.
- Maker
- Datascope Corp. / Maquet Cardiovascular (Getinge)
- Model
- Cardiosave Hybrid Intra-Aortic Balloon Pump
- Device type
- Intra-aortic Balloon Pump
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Therapy principle | Counterpulsation: IAB inflates at the onset of diastole and deflates at or just before systole | Source |
| Battery | Hot-swappable lithium-ion batteries replacing the sealed lead acid battery of the CS300 | Source |
| Autofill method | Pressure-based Autofill (changed from the volume-based process of the predicate) | Source |
| Fibre-optic calibration | With a Getinge fibre-optic IAB catheter, calibrates in the patient at start-up and every 2 hours | Source |
| Configurations | Hybrid on the hospital cart; Rescue off the cart for transport | Source |
| FDA clearance | 510(k) K112372 (2011), 21 CFR 870.3535, product code DSP; predicate CS300 (K063525) | Source |
Recalls
Known FDA recalls.
- Z-3134-20242024-08-08
Software correction (D.00) to address risks of haemodynamic instability and loss of clinical data transmission.
FDA record - Z-2433-20232023-07-31
System Over Temperature alarms with loss of pumping or entry to Standby.
FDA record - Z-2435-20232023-07-31
Gas Loss and Gas Gain alarms, with triggers not listed in the IFU and hardware issues.
FDA record - Z-2437-20232023-07-31
Autofill failure conditions causing pump stops.
FDA record - Z-2151-20232023-06-05
Unexpected shutdown from tantalum capacitor failures on power management and solenoid boards.
FDA record - Z-1229-20232023-02-07
High pressure helium regulator failures causing helium leaks in the hospital cart.
FDA record
Safety
Safety warnings from the record.
- Unexpected shutdowns from board failures interrupt therapy, so Getinge recommends keeping an alternate IABP available. Source
- Fluid ingress can short electronic boards and stop therapy, so keep fluids away from the console. Source
- Blood entering the pump from a perforated balloon can shut it down and contaminate internal parts. Source
- Above 3,200 ft altitude some consoles could fail to start or keep therapy going, which matters for air transport. Source
Sources
Where this note comes from.
- Getinge, Cardiosave Hybrid IABP product page (Sweden, English)
- FDA 510(k) summary K112372, Cardiosave IABP
- openFDA recall search, Cardiosave
- openFDA MAUDE problem counts, Cardiosave
Not covered: Getinge's brochure, quick reference guide and US product pages could not be retrieved, so weight, battery run time and helium specifications are missing. Alarm entries come only from FDA recall notices, not from the full operating instructions.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Intra-aortic Balloon Pump
Other models of this device.
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