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FDA designates recall of LVAD as Class 1
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The FDA has designated Abbott’s product recall of a left ventricular assist system for the short-term treatment of patients who are at risk for death from end-stage LV HF as a Class 1 recall, the most serious kind.
The recall affects 4,878 systems from all manufacturing dates, which were distributed from September 2, 2014 to present.
A malfunction in the outflow graft assembly in the device (HeartMate 3 Left Ventricular Assist System, Abbott) can cause the graft to occlude over time, according to a MedWatch report from the FDA. This can affect the pump flow and lead to a persistent low flow alarm. This reduction in the pump can increase a patient’s risk for serious adverse events such as death and blood clots.
Abbott distributed an urgent medical device recall notification to physicians on May 21, 2018, alerting them of the device malfunction and instructions on how to manage patients who are either getting the device or already have it implanted. The company recommends not removing the device, instead performing imaging tests — first transthoracic echocardiography, then CT angiogram if necessary — to determine whether a patient has an outflow graft twist occlusion.
If surgical repair of the outflow graft is required due to twist occlusion, the outflow graft bend relief should be reattached in its original state or repaired, according to the safety alert from the FDA.