A troubled #heart #pump that has now been linked to 🔸49 deaths 🔸and dozens of injuries worldwide will be allowed to remain in use,
despite the Food and Drug Administration’s decision to issue an alert about the risk that it could puncture a wall of the heart.

The tiny #Impella pumps, about the width of a candy cane, are threaded through blood vessels to take over the work of the heart in patients who are undergoing complex procedures or have life-threatening conditions.

The F.D.A. said the manufacturer of the device, #Abiomed, should have notified the agency more than two years ago, when the company first posted an update on its website about the perforation risk.

Such a notice, the F.D.A. added, would have led to a much broader official agency warning to hospitals and doctors.
The alert is the latest of concerns raised in recent years about the deadly side effects of #cardiac #devices, especially those that take over the heart’s role in circulating blood.
It is the third major F.D.A. action for an Impella device in a year.

https://www.nytimes.com/2024/03/29/health/fda-heart-pump-fatalities.html?smid=nytcore-ios-share&referringSource=articleShare