FDA Class I Recall for HeartMate 3 Left Ventricular Assist System

Susan Jeffrey

May 22, 2018

The US Food and Drug Administration (FDA) has identified a recall of the HeartMate 3 Left Ventricular Assist System (Abbott) as Class I, the most serious type of recall, because of the risk for serious injury or death, after it was determined that problems with the device's outflow graft assembly may lead to graft occlusion.

"Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system," a statement from the FDA posted May 22 said. Such reductions can lead to serious adverse events including blood clots and death, it notes.

Patients experiencing a persistent low-flow alarm should contact the physician managing their device "immediately," they write. However, "Abbott is recommending not to remove the device because of this issue."

The recalled product is the HeartMate 3 system, model/item numbers: catalog #106524US (US commercial), 106524 (US Investigational Device Exemption number), and 10652INT (international). The recall affects all lots and all manufacturing dates with distribution between September 2, 2014, and present. Recalled systems in the United States total 4878 devices nationwide.

"Following communications on April 5, 2018, and May 4, 2018, respectively, Abbott sent an Urgent Medical Device Recall notification to physicians on May 21, 2018, alerting them again to the device malfunction and providing them with the following instructions for managing patients getting the device or patients who already have the device implanted," the statement said.

  • "Patients should be followed per recommendations from the American Society of Echocardiography (J Am Soc Echocardiogr 2015;28:853-909), which states that 'An LVAD surveillance echo exam should be considered at approximately 2 weeks after device implantation or before index hospitalization discharge (whichever occurs first), followed by consideration of surveillance transthoracic echo (TTE) at 1, 3, 6, and 12 months post implantation and every 6 to 12 months thereafter.'

  • TTE imaging is not a definitive tool to identify an outflow graft twist obstruction. However, it can be used as an indirect assessment of obstruction by imaging the size of the left ventricle, the mitral valve and aortic valve opening, and diastolic velocity (inflow or outflow).

  • A decrease in flow over time may be an indicator of Outflow Graft twist obstruction. If such a trend in flow is observed, or if flow velocity anywhere in the Outflow Graft exceeds 2 meters/sec (J Am Soc Echocardiogr 2015;28:853-909), more frequent surveillance echo exams than listed above, or other investigative methods, may be necessary.

  • If a persistent low flow alarm (ie, a low flow alarm not resolved after all relevant patient medical conditions having been ruled out as the cause) occurs at any time following implant, a Computed Tomography (CT) angiogram should be urgently obtained, if there are no contraindications, to identify a possible outflow graft twist occlusion.

  • In the event that surgical repair of the Outflow Graft is needed due to a twist occlusion, the Outflow Graft Bend Relief should be reattached in its original state or repaired to prevent bending, abrasion or occlusion of the outflow graft at the graft's attachment point to the pump."

Those who want more information about this recall can contact their local Abbott Mechanical Circulatory Support (MCS) Clinical Specialist or MCS HeartLine at 1-800-456-1477, the statement adds.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

The recall notice can be found here.

A spokesperson for Abbott pointed out that no devices are being recalled from patients or hospitals. "As a follow up to our initial April communication, Abbott has provided a second update to physicians to reinforce patient management recommendations," the company said.

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