US health regulators are warning surgeons to stop applying heart pumps tied to recent strokes and more than a dozen deaths
Medtronic said earlier in the day that it would stop selling its HeartWare Assist device, which aims to boost blood circulation in patients with heart failure.
Recent company data showed that the device can unexpectedly stop working and sometimes fail to restart, the Food and Drug Administration said. The company said it has not been able to trace the root cause in every case.
Surgeons can use implants from other manufacturers, the FDA said in a memo to physicians.
About 4,000 people worldwide currently have a Medtronic device, about half of them in the US, the agency said, adding that US doctors should contact the company for the latest guidance on managing the device, including managing blood pressure.
The FDA said Medtronic halted sales after reviewing 100 reports of power failures with the device, which led to the deaths of 14 patients and the removal of 13 patients. The company had previously issued a recall on certain hardware devices and the components used when implanting it. In December, the company warned about a power failure or delay in restart with three lots.
The company said that patients should not remove the device on their own. Missed heart transplants need to be carefully weighed against the potential risks of surgery. Medtronic said in a statement that physicians “should, on a case-by-case basis, consider patients’ clinical status and surgical risks.” The company said it is preparing a guide for managing patients who “might need support for many years.”
Heartware devices were used as permanent implants for heart failure patients awaiting transplantation or for those who were not 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 equipment and equipment manufacturers, selling thousands of implants used to treat cardiovascular, neurological and joint conditions.
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.