Freedom Drive Recall for SynCardia Total Artificial Heart Categorized as Class I by FDA
The driver system for a SynCardia total artificial heart replacement has been recalled, following reports that the power supply could fail, potentially causing patients to suffer serious injury and death.
The FDA announced last week that a recall of SynCardia Freedom Driver Systems for the temporary Total Artificial Heart (TAH-t) is categorized as a class 1 medical device recall, suggesting that continued use of the product poses a risk of serious adverse events or fatal injury.
The TAH-t system is a mechanical heart replacement implanted in patients who are at risk of imminent death from heart failure and are awaiting a heart transplant. The pump is implanted into the patient’s chest to replace the left and right ventricles and is sewn to the remaining top half of the heart.
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The pump is operated by a Freedom Driver System, which is attached to the TAH-t pump. The Freedom Driver System controls the pump and supplies power, designates the pumps operating speed, and allows patients and doctors to monitor the pumps activity.
The initial recall came after the manufacturer recognized a potential that the mechanism inside of the driver system may fail and cause the pump to stop operating, which would lead to almost certain loss of consciousness and even death. To date, the FDA is not aware of any serious injuries or deaths associated with the recall.
The FDA’s decision to classify the action as a class 1 recall was based on the potential life threatening hazards associated with the mechanical failure defect. In the event that the driver system experiences a mechanical failure, the TAH-t will lose power and stop pumping blood to the patient’s heart, causing the individual to lose consciousness almost immediately. Class I recalls are considered the most dangerous level of recalls.
The device will not give any notice to the patient that it is beginning or about to fail.
The recall includes Freedom Driver Systems with lot numbers 85978 and serial numbers ranging from 85978-001 through 85978-040, and lot number 85979 with serial numbers ranging from 85979-001 through 85979-040. The devices were sold in conjunction with the SynCardia Temporary Total Artificial Heart.
The recalled drivers were manufactured by SynCardia Systems Inc., of Tucson, Arizona from November 3, 2014 to July 29, 2015 and were distributed for sale to hospitals from November 10, 2014 through July 29, 2015. According to the FDA and the manufacturer, and estimated 29 units were distributed for sale in the U.S.
SynCardia Systems began notifying customers of the recall on August 6, 2015 when the company issued an Urgent Medical Device Recall letter. The letter was sent to all of their customers warning them of the affected drivers and how to replace the impacted drivers with new ones.
Customers are being instructed to notify the patients with the impacted drivers and replace them with new ones immediately. Customers are being asked to fill out all of the attached paper forms included in the Urgent Medical Device letter and to return the recalled drivers for updated replacement drivers. Those with questions or further concerns may contact SynCardia Systems at 866-480-1122, extension 1308.
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