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CentriMag ™ System
* Abbott Data on File.
Abbott 6101 Stoneridge Dr., Pleasanton, CA 94588 USA, Tel: 1 925 847 8600 Cardiovascular. Abbott / CentriMag
CentriMag™ Circulatory Support System Indications [ PMA Approval; 30-day use ]: Temporary circulatory support for up to 30 days for one or both sides of the heart to treat post-cardiotomy patients who fail to wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient’ s heart will recover or whether the patient will need alternative, longer-term therapy. CentriMag™ Circulatory Support System Contraindications [ PMA Approval; 30-day use ]: The CentriMag™ Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
CentriMag™ Circulatory Support System Adverse Events [ PMA Approval; 30-day use ]: Adverse events that may be associated with mechanical circulatory support can include, but are not limited to, the following: bleeding on device support, hemolysis, infection, renal failure / dysfunction / complication, respiratory dysfunction, hepatic dysfunction, cardia arrhythmias( atrial or ventricular), thromboembolism( venous and arterial non-CNS), hypotension, hypertension, device malfunction or failure, psychiatric events, right heart failure, and death.
CentriMag™ RVAS Indications [ Humanitarian Exemption Device( HDE) Approval; 30-day use ]: The CentriMag Circulatory Support System is intended to provide temporary circulatory support for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure.
CentriMag™ RVAS Contraindications [ Humanitarian Exemption Device( HDE) Approval; 30-day use ]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
Humanitarian Device Statement: Caution: Humanitarian Device. The CentriMag Circulatory Support System is authorized by Federal Law for temporary circulatory support for up to 30 days for patients in cardiogenic shock due to right ventricular failure. The effectiveness of this device for this use has not been demonstrated.
™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third-party trademark, which is property of its respective owner. © 2025 Abbott. All Rights Reserved. MAT-2511555 v1.0 | Item approved for U. S. use only.