Class I recall issued for Abbott’s HeartMate 3 heart pump

Daniel Allar | | Cardiovascular Business | Heart Failure
The Abbott HeartMate 3 left ventricular assist system. When Medicare updated its policy on left ventricular assist devices (LVADs) in 2020, making it easier for heart failure patients to receive an LVAD at a health center that does not perform heart transplants, the change was designed to improve patient access and boost outcomes. However, new research published in JAMA Network Open suggests shift may have potentially caused patients to miss out on heart transplants they would have otherwise received.

The FDA has issued a Class I recall of the HeartMate 3 Left Ventricular Assist System (Abbott) because a malfunction in the device’s outflow graft assembly could lead to graft occlusion, possibly reducing or stopping blood flow.

This occurrence may result in blood clots and death, according to the FDA’s statement on the recall, which affects 4,878 units in the U.S. distributed since September 2014. The HeartMate system is designed to provide circulatory support for patients with end-stage left ventricular heart failure and includes an outflow graft that connects a blood pump to the aorta.

Occlusion of the outflow graft would trigger a low-flow alarm in the device. The FDA said patients experiencing this alarm should contact their physicians immediately, although Abbott doesn’t recommend removing the device because of this issue.

Abbott began contacting physicians last month about the potential problem with the heart pumps. Thirty-two incidents of outflow graft twisting—including three related patient deaths—had been reported prior to the company issuing a press release on May 4. Abbott sent specific instructions to physicians for managing patients on May 21 as part of an urgent recall notification, according to the FDA.

The FDA said customers seeking more information can contact Abbott’s 24/7 Mechanical Circulatory Support HeartLine at 1-800-456-1477.

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Daniel Allar

Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.

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