Model note · ECMO
Abbott CentriMag Acute Circulatory Support System
CentriMag is Abbott's extracorporeal centrifugal blood pump system with a fully magnetically levitated rotor. It is used as the pump in ECMO circuits and for short term ventricular support. One console drives one disposable pump through a reusable motor, while an optional Mag Monitor gives a second display and can oversee two consoles in biventricular support. It is widely used in cardiac ICUs. Its recall history centres on the motor cable, pump locking, EMI and power surge immunity.
The model
Maker, model and type.
- Maker
- Abbott (formerly Thoratec Corporation; originally Levitronix LLC)
- Model
- CentriMag Acute Circulatory Support System (2nd Generation Primary Console, motor 102956, blood pump 102953)
- Device type
- ECMO
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Pump | Single use polycarbonate centrifugal pump, fully magnetically levitated, no bearings or seals; 3/8 inch barbed inlet; priming volume 31 mL | Source |
| Speed range | 0 to 5,500 RPM; typical operation 3,000 to 5,000 RPM; at least 1,000 RPM needed for forward flow | Source |
| Flow and pressure | Up to 10 L/min or a maximum pressure head of 600 mmHg | Source |
| Flow probe | Clamp on ultrasonic em-tec adult flow probe, 3/8 x 3/32 inch tubing, optimised for 0 to 10 L/min | Source |
| Pressure monitoring | Two pressure channels (P1, P2), range -150 to 900 mmHg, zeroable during support | Source |
| Console battery | Internal Li-ion pack; at least 120 minutes at 3,500 RPM and 5.5 L/min; recharge to 90% in 4 hours or less and 100% in 5 hours or less; at least 100 charge cycles | Source |
| Power | Single phase AC mains for the 2nd Generation Primary Console | Source |
| Regulatory status | 510(k) for bypass under 6 hours and for ECMO circuits (product codes DWA, QNR; e.g. K234118 decided 26 January 2024); PMA P170038 for up to 30 days of post cardiotomy ventricular support | Source |
Recalls
Known FDA recalls.
- Z-1099-20262025-10-10
Pump may not fit or lock securely into the motor, and the pump not inserted alarm may not trigger.
FDA record - Z-2215-20242024-05-22
2nd Generation console may not meet IEC 61000-4-5 and can shut down without alarm after a surge.
FDA record - Z-0221-20202019-08-22
Motor and pump problems caused by electromagnetic interference.
FDA record - Z-0103-20192018-09-05
Motor stops from wire breaks or shorts at the motor cable bend protection.
FDA record - Z-1901-20082008-03-17
Support could be interrupted when used with a Valleylab Force FX-C electrosurgical unit.
FDA record
Safety
Safety warnings from the record.
- A pump not locked into the motor may not alarm and can lead to delayed support, embolism, stroke or death. Source
- After a large power surge an affected console may stop pumping completely with no alarm, so a backup system must be ready. Source
- The system is contraindicated as a cardiotomy suction device and for patients who cannot take anticoagulation such as heparin. Source
- The pump is afterload sensitive and preload dependent, so filling pressure and mean arterial pressure affect flow. Source
Sources
Where this note comes from.
- Abbott CentriMag product information (US)
- Abbott CentriMag pump parameter guide
- FDA PMA P170038 Summary of Safety and Effectiveness Data, CentriMag Circulatory Support System
- FDA 510(k) K234118 summary, CentriMag Acute Circulatory Support System
- openFDA recall search, CentriMag
- openFDA MAUDE problem counts, brand CentriMag
Not covered: The CentriMag operating manual with its full alarm list is not publicly posted, so only one alarm named in an FDA recall is listed. Console dimensions, weight and electrical ratings were not found in an opened source. MAUDE counts include many reports with insufficient information and are not a failure rate. 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.
ECMO