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Medtronic Stops Selling Heart Pump Device Tied to 13 Deaths, FDA Issues Warning

For patients that still have the pump, the FDA said U.S. doctors should contact the company for the latest guidance on managing the device, which includes managing blood pressure.

2021-06-03 16:06

An issue with power failures and delayed restarts, which may have caused multiple deaths and several strokes has led to a recall being issued for the Medtronic HVAD Pump Implant heart pump. Medtronic and the Food and Drug Administration (FDA) have issued a recall for these heart pumps that are in about 4,000 people worldwide, the Associated Press reported. "There have been 29 complaints about this device issue, which include 19 serious injuries and 8 cases of patients who had a life-threatening event but recovered without long term effects," the FDA said in a statement. According to the FDA, the HVAD Pump Implant Kit will sometimes fail to start, causing a delay after the pump has been stopped. This can cause serious injuries or further complicate heart failure problems. For more reporting from the Associated Press, see below.

Earl Brakken, Co-Founder Of Medtronic — KAMUELA, HI: SEPTEMBER 9: Earl Bakken reflects on his role in the Heart Brain Center and the North Hawaii Community Hospital in 2005. Bakken co-founded Medtronic, Inc. and has set a personal goal of establishing... Alvis Upitis/Getty Images

For patients that still have the pump, the FDA said U.S. doctors should contact the company for the latest guidance on managing the device, which includes managing blood pressure. The FDA said Medtronic halted sales after reviewing 100 reports of power failures with the device, which led to 14 patient deaths and 13 patients having it removed. The company previously issued recalls on some Heartware devices and components used when implanting it. In December, the company warned about power failures or delayed restarts with three lots. The company said patients should not automatically have the device removed.

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Taking out recalled heart implants has to be carefully weighed against the potential risks of surgery. Medtronic said in a statement physicians should decide "on a case-by-case basis, considering the patients clinical condition and surgical risks." The company said it is preparing a guide for managing patients "who may require support for many years." The Heartware device was used for heart failure patients awaiting transplant or as a permanent implant for those who weren't healthy enough for that procedure. The device helps strengthen one of the heart's lower chambers needed for adequate blood circulation. Medtronic is one of the world's largest medical device and equipment makers, selling thousands of implants used to treat heart, neurological and joint conditions.