The FDA issued its most serious level of recall, a Class I, on SynCardia Systems Total Artificial Heart Freedom Driver due to a potentially deadly defect.Part of the driver may fail, causing the artificial heart to stop pumping blood. This can result in serious injuries, up to and including death, if the patient is not immediately connected to a new driver.
UPDATE! SynCardia advised in a press release earlier today that ALL of the defective Freedom Drivers were, in fact, recovered and replaced by August 14. I am happy to receive and report this information, as it means that no one is in danger. Furthermore, SynCardia reports that the defective components were supplier-provided parts that had been modified without SynCardia’s knowledge.
The FDA issued Class I recall SynCardia Systems Freedom Driver for its Total Artificial Heart. The is the most serious recall the agency can issue and it means, “There is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The Freedom Driver system is the part being recalled. It is hooked up to the SynCardia Artificial Heart to monitor and regulate its operation. The Heart itself is a unique pump that is surgically implanted into the patient’s chest. It takes over the functions of the left and right ventricles of the patient’s heart.
This is a truly frightening recall. There is a component of the Freedom Driver unit that may fail. If it fails, the Syncardia Artificial Heart ceases its pumping action. In other words, the patient experiences total heart failure. There is no advance warning of the Freedom Driver malfunction; the only notice the patient gets is the almost immediate loss of consciousness. Unless the Artificial Heart is quickly attached to a backup Freedom Driver, the patient will be seriously injured or die.
There is a red light and loud continuous alarm from the Freedom Driver when it fails. However, the alert comes only after the failure. If the patient is alone, there is nothing that can be done. If someone is with the patient, that person should immediately get the patient hooked up to a new Freedom Driver and call 911. The patient must be evaluated for injury.
SynCardia became aware of the issue earlier this summer, according to the FDA. The company began telling customers about it on August 6, advising hospitals to replace the affected drivers. Fortunately, the number of units that are defective is low, only 29.
The recalled units were manufactured between November 3, 2014 and July 29, 2015. The lot numbers and serial numbers in the recall are listed below.
Lot #85978
Serial numbers 85978-001 through 85978-040.
Lot #85979
Serial numbers 85979-001 through 85979-040.
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