{"id":2654,"date":"2024-04-16T19:02:24","date_gmt":"2024-04-16T19:02:24","guid":{"rendered":"https:\/\/healthynewsusa.com\/?p=2654"},"modified":"2024-04-16T19:02:26","modified_gmt":"2024-04-16T19:02:26","slug":"fda-announces-recall-of-heart-pumps-linked-to-deaths-and-injuries","status":"publish","type":"post","link":"https:\/\/healthynewsusa.com\/?p=2654","title":{"rendered":"FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries"},"content":{"rendered":"
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A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA\u2019s most serious recall, the agency announced Monday<\/a>.<\/p>\n

The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. The devices are not currently being removed from the market. Abbott did not respond to KFF Health News\u2019 requests for comment.<\/p>\n

The delayed action raises questions for some safety advocates about how and when issues with approved medical devices should be reported. The heart devices in question have been associated with thousands of reports of patients\u2019 injuries and deaths, as described in a KFF Health News investigation late last year<\/a>.<\/p>\n

\u201cWhy doesn\u2019t the public know?\u201d said Sanket Dhruva<\/a>, a cardiologist and an expert in medical device safety and regulation at the University of California-San Francisco. Though some surgeons may have been aware of issues, others, particularly those who do not implant the device frequently, may have been in the dark. \u201cAnd their patients are suffering adverse events,\u201d he said.<\/p>\n

The recall involves a pair of mechanical pumps that help the heart pump blood when it can\u2019t do so on its own. The devices, small enough to fit in the palm of a hand, are implanted in patients with end-stage heart failure who are waiting for a transplant or as a permanent solution when a transplant is not an option. The recall affects more than 13,000 devices.<\/p>\n

The HeartMate 3 is a mechanical pump designed for patients with end-stage heart failure and manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. Known as a left ventricular assist device, the HeartMate 3 helps the main pumping chamber of the heart pump blood to the rest of the body. The device can be used by patients awaiting a heart transplant or for long-term therapy. The device is powered by a cable that is attached to the pump and exits the body through a surgical opening and connects to a controller and batteries or other power source, according to the manufacturer\u2019s instruction manual<\/a>. (Diagram: Abbott Laboratories 2017 instruction manual, Page 38. The same diagram is also featured in the 2022 instruction manual, which can be found by searching Abbott\u2019s website.)<\/span><\/figcaption><\/figure>\n

Amanda Hils, an FDA press officer, said the agency is working with Abbott to investigate the reported injuries and deaths and determine if further action is needed.<\/p>\n

\u201cTo date, the number of deaths reported appears consistent with the adverse events observed in the initial clinical trial<\/a>,\u201d Hils said in an email.<\/p>\n

According to the FDA\u2019s recall notice, the devices can cause buildup of \u201cbiological material\u201d that reduces their ability to help the heart circulate blood and keep patients alive. The buildup accumulates gradually and can appear two years or more after a device is implanted in a patient\u2019s chest.<\/p>\n

Doctors were advised to watch out for \u201clow-flow alarms\u201d on the devices and, if they do diagnose the obstruction, to either monitor the patient or perform surgery to implant a stent, release the blockage, or replace the pump.<\/p>\n

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A review of the FDA device database shows at least 130 reports related to HeartMate II or 3 that mention the complication reported by regulators. The earliest such report filed with the FDA dates to at least 2020, according to a KFF Health News review of the database.<\/p>\n

Monday\u2019s alert is the second Class 1 recall of a HeartMate device this year.<\/p>\n

In January, Abbott issued an urgent \u201ccorrection letter<\/a>\u201d to hospitals about a separate issue<\/a> in which the HeartMate 3 unintentionally starts and stops due to the pump\u2019s communication system, which cardiologists use to assess patients\u2019 status. The FDA alerted the public<\/a> in March.<\/p>\n

In February, Abbott issued another urgent letter<\/a> to hospitals about the blockage problem, asking them to inform physicians, complete and return an acknowledgment form, and pay attention to low-flow alarms on the device\u2019s monitor that may indicate an obstruction. The company said in the letter that it is working on \u201ca design solution\u201d to prevent the blockages.<\/p>\n

A study published in 2022<\/a> in the Journal of Thoracic and Cardiovascular Surgery reported the obstruction in about 3% of cases, though the incidence rate was higher the longer a patient had the device.<\/p>\n

The only other Class 1 recall issued for the HeartMate 3<\/a> was in May 2018, when the company issued corrective action notices to hospitals and physicians warning that the graft line that carries blood from the pump to the aorta could twist and stop blood flow.<\/p>\n

The FDA recall notice issued Monday includes additional guidance for physicians<\/a> to diagnose the blockage using an algorithm to detect obstructions and, if needed, a CT angiogram to verify the cause.<\/p>\n

At present, the HeartMate 3, which was first approved by the FDA in 2017, is the only medical option for many patients with end-stage heart failure and who do not qualify for a transplant. The HeartMate 3 has supplanted the HeartMate II, which received FDA approval in 2008.<\/p>\n

If the new recall leads to the device being removed from the market, end-stage heart failure patients could have no options, said Francis Pagani<\/a>, a cardiothoracic surgeon at the University of Michigan who also oversees a proprietary database of HeartMate II and HeartMate 3 implants.<\/p>\n

If that happens, \u201cwe are in trouble,\u201d Pagani said. \u201cIt would be devastating to the patients to not have this option. It\u2019s not a perfect option \u2014 no pump ever is \u2014 but this is as good as it\u2019s ever been.\u201d<\/p>\n

It\u2019s not known precisely how many patients have received a HeartMate II or HeartMate 3 implant. That information is proprietary. The FDA recall notices show worldwide distribution of more than 22,000 HeartMate 3 devices<\/a> and more than 2,200 of the HeartMate II<\/a>.<\/p>\n

The blockage complication may have gone unreported to the public for so long partly because physicians are not required to report adverse events to federal regulators, said Madris Kinard, a former FDA medical device official and founder of Device Events<\/a>, a company that makes FDA device data more user-friendly for hospitals, law firms, and investors.<\/p>\n

Only device manufacturers, device importers, and hospitals are required by law<\/a> to report device-related injuries, deaths, and significant malfunctions to the FDA.<\/p>\n

\u201cIf this is something physicians were aware of, but they weren\u2019t mandated to report to the FDA,\u201d Kinard said, \u201cat what point does that communication between those two groups need to happen?\u201d<\/p>\n

Dhruva, the cardiologist, said he is looking for transparency from Abbott about what the company is doing to address the problem so he can have more thorough conversations with patients considering a HeartMate device.<\/p>\n

\u201cWe\u2019re going to expect to have some data saying, \u2018Hey we created this fix, and this fix works, and it doesn\u2019t cause a new problem.\u2019 That\u2019s what I want to know,\u201d he said. \u201cThere\u2019s just a ton more that I feel in the dark about, to be honest, and I\u2019m sure that patients and their families do as well.\u201d<\/p>\n