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COMPANY ANNOUNCEMENT

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Summary

Company Announcement Date:
May 04, 2018
FDA Publish Date:
May 31, 2018
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
potential safety risk to patients, such as low blood flow or clotting.
Company Name:
Abbott
Brand Name:
Brand Name(s)
HeartMate 3
Product Description:
Product Description
Left Ventricular Assist Device

Company Announcement

Abbott is communicating to physicians about a field corrective action related to the HeartMate 3™ Left Ventricular Assist Device (LVAD). Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting.

No devices are being recalled from patients or hospitals as a result of the corrective action, and the recommendations made by Abbott remain in place for physicians managing patients implanted with HeartMate 3.

Abbott is currently aware of 32 reports of outflow graft twisting in 4,467 HeartMate 3 devices worldwide (incidence rate of 0.72%), including reports of low blood flow, clotting (known as thrombus), and three reported deaths that could be associated with outflow graft twisting. As a result, Abbott has contacted physicians managing patients implanted with a HeartMate 3 LVAD in the event their patients report persistent low flow alarms that could indicate outflow graft twisting. Twisting of the outflow graft can occur at any point after implant.

In patients living with an LVAD, low flow alarms can often indicate unrelated conditions such as hypertension. For patients who experience a persistent low flow alarm after such causes have been ruled out, a computed tomography (CT) scan can help detect any possible outflow graft twisting. In addition, physicians managing patients that exhibit a persistent low flow alarm should determine patient care recommendations based on each unique clinical case.

Abbott has also alerted implanting physicians that as stated in the device’s instructions for use (IFU), properly hand tightening the screw ring at the time of implant may reduce the chance of outflow graft twisting. Abbott has proactively contacted all physicians who treat patients impacted by this safety alert and will continue to assess current reports of outflow graft twisting to further provide physicians with patient care recommendations.


Company Contact Information

Media:
Justin Paquette
651-756-6293