Last week, the FDA issued a Class I recall for an artificial heart system which could experience a power fail resulting in serious injury or even the death of a patient.
The initial recall for the SynCardia Freedom Driver Systems for the temporary Total Artificial Heart (TAH-t) was issued in August, but the FDA announced that the recall was now categorized in FDA Class I on September 22. A Class I recall is the most serious level of recall issued by the FDA, reserved for instances where it is determined that “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
The SynCardia Total Artificial Heart system acts as a temporary replacement heart for patients in immediate danger of heart failure, many of whom are awaiting a heart transplant. The device replaces the left and right ventricles. Specifically, this recall affects the Freedom Driver System of the temporary artificial heart. This is the part which supplies power to the artificial heart, establishes operating speed, and gives doctors and patients the ability to monitor the pump.
The manufacturer recently realized that the Freedom Driver may suddenly lose power and stop working. This means that the patient’s “heart” will immediately stop. In the best situations, patients will immediately lose consciousness but may survive if a backup Driver is attached to his or her artificial heart. Otherwise, the patient will suffer permanent injury or even death.
When the Freedom Driver fails, it emits a loud alarm and flashes a red light. However, these warnings only take place after failure and will be of little use to patients who are already unconscious.
SynCardia began to notify patients of this potential defect immediately when it was discovered, and the patient’s hospitals were also notified so that they could immediately replace affected units. So far, only 29 individual units sold in the United States are believed to be affected by the recall.
Recalled SynCardia Freedom Drivers were manufactured from November 3, 2014 to July 29, 2015 and will be marked with the following lot and serial numbers:
• Lot #85978: Serial numbers 85978-001 through 85978-040
• Lot #85979: Serial numbers 85979-001 through 85979-040
Though SynCardia acted promptly once the defects were noticed in their Freedom Drivers, it is still possible that some patients did not receive their notifications and may be at serious risk for injury or death. When medical devices patients trust with their lives are found to be defective or otherwise dangerous, catastrophe may result.
If you or someone you love has been injured or even killed as a result of a medical device you believe is dangerous or defective, you may have grounds to pursue compensation in a medical product liability lawsuit. Please contact an experienced personal injury lawyer to learn more in a free consultation.
