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The U.S. Food and Drug Administration (FDA) is alerting health care providers to the possibility that patients who have the Medtronic Heartware Ventricular Assist Device (HVAD) System and appear to present with pump thrombosis may have a welding defect in the internal pump causing the pump to malfunction.

This week, Medtronic issued an Urgent Medical Device Correction to inform health care providers of the pump weld defect. Medtronic is conducting an investigation to identify which HVAD pumps may be affected. The FDA is issuing this letter to health care providers to ensure you are aware of this defect and the recommended actions to take to manage the care of patients currently implanted with a Medtronic HVAD system. As stated in the FDA’s June 2021 communication, the FDA does not recommend the elective removal of properly functioning systems. Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks.

The Medtronic HVAD System is a durable left ventricular assist device (LVAD) that includes peripheral components (such as controllers, batteries, AC/DC adapters, carrying case) and was first approved for commercial use in the United States in November 2012. It is approved as a bridge to heart transplantation in patients who are at risk of mortality from end-stage left ventricular heart failure, for heart tissue recovery, and as destination therapy in patients for whom a heart transplant is not planned.

Medtronic received three complaints of patients with suspicion of pump thrombosis where inspection of the returned pumps identified a malfunction of the internal pump in the Medtronic HVAD System. A pump exchange was performed for all three patients, and of these three patients, two patients died after the pump exchange. The three patients involved presented with one or more of the following signs or symptoms:

The FDA will continue to work with Medtronic to:

The FDA will keep health care providers and the public informed if new or additional information becomes available.

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with the Medtronic HVAD System.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).