The horror is almost unthinkable.
Your chest is cut wide open… you’re flat on your back in the operating room for hours on end… and you’re hooked up to a machine that keeps your blood pumping and circulating while they work on your heart.
The contraption is keeping you alive… but then it FAILS.
The screen goes blank on the console – and that’s the part controls how fast and hard the blood is pumped through your body.
Alarms are going off… but your surgical team can’t be sure whether they’re accurate…
Or just on the fritz.
If the cardiology staff is using a specific brand of one of these machines that was distributed in the U.S. between November 22, 2017 and August 6, 2019… that’s EXACTLY what could happen.
In fact, it already has. At least one person has ALREADY died as a result.
Others have been seriously injured.
And the SCARIEST part is that even when you’ve already SURVIVED open-heart surgery…
You’re not out of the woods.
Because if you’re struggling with heart failure, you might be using one of these machines at home… or in your managed care facility… right now.
If you are… or you’re a caregiver of someone who is… here’s the shocking new device recall you need to know about.
The LAST thing you need when you’re on the mend
The CentriMag circulatory support system isn’t just used in the operating room during open-heart procedures.
It also helps support healthy blood circulation if you’ve gone into cardiogenic shock after a heart attack… or any other reason your heart might need some pumping help (e.g. acute right ventricular failure).
Here in this country, 381 devices are being RECALLED by its manufacturer, a company called Abbott.
The FDA considers it a Class I recall — the most serious kind of recall there is.
And we know how EAGER the feds are to hit the panic button when it comes to device safety. (Yeah, right!)
But that just shows you what a MAJOR — and potentially deadly – issue this is.
In one of these devices that’s being recalled, its pump may SLOW… or STOP altogether.
If that happens to you, you could have a stroke… suffer severe organ damage… or die.
When Abbott initiated the recall in August, the company had ALREADY received reports of 44 injuries and 1 death.
If you ask me, that’s one death too many!
But those numbers COULD be higher now, more than two months later.
So, why would the pumping just slow or stop? What goes wrong?
The device maker is calling it a “calibration system error resulting from electromagnetic interference.”
And that’s perhaps the most DISTURBING aspect of this device malfunction or failure risk.
Sources of “electromagnetic interference” could be pretty much anything electronic… or electrical.
In the OR, that could mean positioning the console too close to ANY other machine used in surgical settings.
At home, it could be your cordless phone… heating pad… electric blanket… or even your doorbell!
You can’t even plug the CentriMag machine into a power strip or surge protector!
The manufacturer’s solution?
Move the console away from the source… or remove the source altogether.
But you’d have to identify the source in the blink of an eye…
And you’re not moving ANYTHING if you’re the one who’s hooked up to the gosh-darned thing.
Same goes for switching the pump to the backup system, which you’re also supposed to do when an electromagnetic interference issue occurs.
Sure, the device’s operating manual tells you how to do it…
But who can understand ANY operating manual (much less find where you put it)??
And by then, it may already be too late.
Make no mistake – this recall is BIG.
It affects countries all over the world… from Europe to South America, Asia, the UK, and the Middle East.
Here in the U.S., Abbott has set up a 24-hour hotline for concerned customers. Call 1-800-456-1477 (or have your caregiver call for you) and give them the business, big time.
Get THEM to come fix it – or better yet, REPLACE it – themselves.
And if you get injured as a result of this glitch, don’t hesitate to lawyer up.