The agency faulted the device maker for delayed notice of mounting complications, citing increasing reports of how use of the device perforated the walls of the heart.
I misread it as heat pump, was sure I was wrong, read it again and got it wrong again. So... I guess I'm glad you wrote this comment to get me to read it a third time.
Well, in this particular patient population, I think you're kind of damned if you do, damned if you don't. We always seem to prefer the risk of intervention over the risks of conservative management