The device is made by one of the most trusted medical device manufacturers in the world and it has been used by some of the most respected heart surgeons in the business.
The medical device, manufactured by Lifesciences Corp, is called an IntraClude intra-aortic occlusion. The manufacturer issued a voluntary recall promptly after the FDA issued their emergency Class I recall.
“Edwards takes the safety of patients very seriously,” said Sarah Huoh, company spokesperson. “As we look into this matter further, we are collecting all products back from customers.”
FDA warns of lethal medical device that may rupture during heart surgery
When a patient is undergoing heart surgery, the surgeons can slide the intra-aortic occlusion into the heart’s valves and inflate them like a balloon. This creates an occlusion for the aorta artery, blocking and venting the blood supply, allowing surgeons to repair the damage in the heart valve without interference from other organs.
The device assumes the life-sustaining role of the heart and lungs during surgery. This new device has been around for two years and has been used for heart transplants, aneurysm operations, cardiopulmonary bypasses in valve replacements and for treating birth defects. The problem is that the device is prone to rupture, causing potentially fatal abruptions in surgery that the patient may not recover from. When the IntraClude bursts, it could prolong the surgery, leading to cardiopulmonary bypass, including neurological damage, embolism, stroke and death. In the two years it was used, three patients did not survive the rupture and their families are now dealing with legitimate medical malpractice/wrongful death claims.
The FDA’s Class I recall is a warning to all cardiothoracic surgeons: The device is lethal. The device could be punctured during a heart operation, ultimately causing irreversible damage to the patient’s heart. The recall included seven hundred fifty-seven devices. The devices, issued between May 2017 and February 19, 2019, were being used regularly by well-respected heart surgeons throughout the U.S.
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