Model note · Cardiopulmonary Bypass
LivaNova Stockert S5 System heart-lung machine
The Stockert S5 is LivaNova's modular heart-lung machine for cardiopulmonary bypass, built from a mobile console, a system panel of display and control modules, and console or mast mounted pumps. Roller pumps give occlusive flow and the CP5 centrifugal pump gives non occlusive flow, with bubble, level, pressure and temperature monitors around them. LivaNova calls it the most successful heart-lung machine ever. Its Essenz successor is built on the same base.
The model
Maker, model and type.
- Maker
- LivaNova Deutschland GmbH (formerly Sorin Group Deutschland GmbH)
- Model
- Stockert S5 System heart-lung machine (with Sorin C5 and CP5 centrifugal pump variants)
- Device type
- Cardiopulmonary Bypass
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA classification | Cardiopulmonary bypass heart-lung machine console, 21 CFR 870.4220, Class II, product code DTQ | Source |
| Indication | Cardiopulmonary bypass procedures lasting six hours or less | Source |
| Clearance history | K060053 (June 2006), K062396 (September 2006), K071318 (July 2007), K210130 (decided 5 April 2021) | Source |
| System panel | Display and control modules in 3, 4 (standard), 5 or 6 module slots | Source |
| Console | Holds the electronics and power pack with central power supply, fan and batteries for the uninterruptible emergency supply; pump tables for 3, 4 or 5 pumps | Source |
| Roller pumps | Single roller pump 150 (item 10-80-00) and double roller pump 85 (item 10-85-00, two 85 mm pumps in one housing); continuous or pulse mode | Source |
| Pressure display range | -300 to +800 mmHg, shown in mmHg or kPa | Source |
| Temperature monitor | Up to four temperatures at once from connected probes | Source |
| Bubble sensors | 3/8 inch (9.56 mm) sensor 23-07-50 and 1/4 inch (6.35 mm) sensor 23-07-40; micro bubble detection can be enabled | Source |
| Centrifugal pump drivers | Up to two at once, one arterial and one for venous kinetic drainage | Source |
Recalls
Known FDA recalls.
- Z-0787-20222021-12-17
CP5 drive unit power cable might be missing a ferrite ring.
FDA record - Z-2439-20202019-08-26
SCP pump control panel knob hard or impossible to turn due to angle encoder wear.
FDA record - Z-2866-20162016-08-25
Potential failure of the uninterruptible power supply.
FDA record - Z-0856-20142013-12-04
Pump speed control knob failures with no response on S5/C5 and CP5.
FDA record - Z-0142-20142013-09-24
Malfunction of cardioplegia control on certain S5 models.
FDA record - Z-0271-20132012-09-19
Fault in motor controller alarm and possible pump stop from an out of specification component.
FDA record - Z-0958-20112010-11-12
Touch screen on display and control modules could become unresponsive.
FDA record
Safety
Safety warnings from the record.
Sources
Where this note comes from.
- LivaNova S5 product page (US)
- LivaNova S5 product catalogue
- FDA 510(k) K210130 summary, Stockert S5 System
- openFDA recall search, S5 heart-lung machine
- openFDA MAUDE problem counts, brand Stockert S5
Not covered: The S5 operator and service manuals are not publicly posted by LivaNova, so only one alarm message from an FDA recall is listed. Flow ranges, battery run time and electrical ratings were not stated clearly in an opened official source. The 3T heater-cooler, a separate product often used with the S5, has its own major recalls for mycobacterial contamination; they are left out here. MAUDE reports under the shorter brand S5 are far more numerous but may mix products, so the narrower Stockert S5 count is used. Recall text was read through openFDA because FDA recall pages returned errors at drafting time.
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.
Cardiopulmonary Bypass
Other models of this device.
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