3 patients killed by heart device that ruptured during surgery, FDA reports
- Edwards Lifesciences Corp, a top device manufacturers, issued a voluntary recall of its IntraClude intra-aortic occlusion in May
- An FDA report reveals the recall was linked to deaths
Three Americans have died after a device burst during heart operations like the one Mick Jagger recently underwent, US regulators report.
Edwards Lifesciences Corp, one of the top device manufacturers in the world, issued a voluntary recall of its IntraClude intra-aortic occlusion in May.
The device contains a balloon, which is slid into the heart’s valves and inflated to then take over the heart and lungs’ functions while surgeons repair the necessary damage, such as a damaged valve, as 75-year-old Jagger had earlier this year.
According to a new report from the US Food and Drug Administration, the recall came after three deaths and 22 non-fatal complaints.
Edwards Lifesciences Corp, a top device manufacturers, issued a voluntary recall of its IntraClude intra-aortic occlusion in May. An FDA report reveals the recall was linked to deaths (file image)
Now the FDA has upgraded the recall to a Class I – meaning the device’s faults could render it lethal – as a warning to cardiothoracic surgeons nationwide.
The recall affects around 750 devices distributed across the US between May 2017 and February 19, 2019 which are vulnerable to rupture or puncture.
It is not the only device on the market that performs this function, but the recall will prompt fresh scrutiny of the tools.
They are used for cardiopulmonary bypasses in valve replacements, transplants, operating on aneurysms, dealing with birth defects, and more.