2nd Generation CentriMag™ Primary Console With Em-Tec Adult Flow Probe

Abbott is notifying users of a potential issue identified through our internal process with the CentriMag™ console (2nd generation CentriMag™ primary console) which is a part of the CentriMag™ Circulatory Support System. Internal testing showed that due to a component change, the CentriMag™ console may not conform to the IEC 61000-4-5 standard. If subjected to a power surge above 1.8kV and up to 2.0 kV, the CentriMag™ console may shut down completely without alarm. A power surge may be caused by, including, but not limited to the following: lightning strike, unregulated power switching, or faulty equipment. Pumping would cease and the patient would have to be switched to a backup.

Recall start date: May 22, 2024