The U.S. FDA today issued a Class I designation — its most serious — over Abbott’s recall of its CentriMag circulatory support system.
By the time Abbott (NYSE:ABT) initiated a recall in August 2019, there were already reports 44 injuries related to electromagnetic interference problems with the system console, according to FDA. The system, which has roots in Levitronix and Thoratec technology, is similar to an LVAD in that it’s a pump providing temporary heart support. It can pump blood through a person undergoing an open-heart procedure, but it can also provide temporary blood circulatory support for up to 30 days to treat cardiogenic shock.
FDA in its Class I notice reported a calibration system error resulting from electromagnetic interference in the CentriMag system’s console — with 381 devices involved in the recall in the U.S. The error has the potential to cause the pump to slow or stop, the console screen to blank, and various inaccurate alarms to sound. If the pump slows or stops during use, the result could be serious injury or death.
“Abbott informed our hospital partners in August about the potential for electromagnetic interference to disrupt the operation of the CentriMag system. All impacted hospitals were made aware of the issue and Abbott replaced improperly configured systems to ensure the safety of our patients,” Abbott spokesperson Kristi Warner said in a statement shared with MassDevice.
Abbott’s recall letter on Aug. 22 said it was acceptable for health providers to continue using the motor until recalibration, as long as it had not exhibited electromagnetic interference problems. The recall notice reminded hospitals that the system has alarms related to electromagnetic interference and that there’s a pump backup system — which all hospitals are required to have. It also warned that electromagnetic interference could affect the performance of the CentriMag console and that the second generation of the console could also affect other nearby equipment.