The Food and Drug Administration has issued a Class I recall for the SynCardia Freedom Driver, warning patients utilizing the SynCardia Total Artificial Heart (TAH-t) with built in Freedom Driver operating and monitoring system the device could fail, putting the patient at risk for serious injury or death. The recall affects lots with serials numbers 85978 and 85979 manufactured and distributed from November 2015 through July 2015.
The SynCardia TAH-t is a mechanical heart pump which replaced the left and right ventricles of a patient’s heart. The SynCardia is sewn to the top half of the patient’s atria and keeps the patient alive while they wait for heart transplant surgery.
The Freedom Drive monitor system in the TAH-t pump may fail and cause the device to cease pumping blood throughout the patient’s body. While an alarm will sound and a red light will illuminate, the FDA admits the warning signals will do the patient little good as consciousness will be lost almost instantly. If a caregiver is not present to switch the TAH-t to backup power, the patient may face serious injury or death.
Class I recalls are the most serious type of recall issued by the FDA. Class I recalls are issued for medical devices whose continued use will likely result in serious injuries or death to the patient.