Connect with us

Kaiser Health News

FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries

Published

on

Daniel Chang and Holly K. Hacker
Tue, 16 Apr 2024 18:20:00 +0000

A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA’s most serious recall, the agency announced Monday.


Related Article


Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk?

The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which the medical device may have caused or contributed to a patient’s death.

Read More

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’ requests for comment.

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’ injuries and deaths, as described in a KFF Health News investigation late last year.

“Why doesn’t the public know?” said Sanket Dhruva, 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. “And their patients are suffering adverse events,” he said.

The recall involves a pair of mechanical pumps that help the heart pump blood when it can’t 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.

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.

“To date, the number of deaths reported appears consistent with the adverse events observed in the initial clinical trial,” Hils said in an email.

According to the FDA’s recall notice, the devices can cause buildup of “biological material” 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’s chest.

Doctors were advised to watch out for “low-flow alarms” 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.

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.

Monday’s alert is the second Class 1 recall of a HeartMate device this year.

In January, Abbott issued an urgent “correction letter” to hospitals about a separate issue in which the HeartMate 3 unintentionally starts and stops due to the pump’s communication system, which cardiologists use to assess patients’ status. The FDA alerted the public in March.

In February, Abbott issued another urgent letter 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’s monitor that may indicate an obstruction. The company said in the letter that it is working on “a design solution” to prevent the blockages.

A study published in 2022 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.

The only other Class 1 recall issued for the HeartMate 3 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.

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

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.

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 cardiothoracic surgeon at the University of Michigan who also oversees a proprietary database of HeartMate II and HeartMate 3 implants.

If that happens, “we are in trouble,” Pagani said. “It would be devastating to the patients to not have this option. It’s not a perfect option — no pump ever is — but this is as good as it’s ever been.”

It’s 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 and more than 2,200 of the HeartMate II.

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 company that makes FDA device data more user-friendly for hospitals, law firms, and investors.

Only device manufacturers, device importers, and hospitals are required by law to report device-related injuries, deaths, and significant malfunctions to the FDA.

“If this is something physicians were aware of, but they weren’t mandated to report to the FDA,” Kinard said, “at what point does that communication between those two groups need to happen?”

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.

“We’re going to expect to have some data saying, ‘Hey we created this fix, and this fix works, and it doesn’t cause a new problem.’ That’s what I want to know,” he said. “There’s just a ton more that I feel in the dark about, to be honest, and I’m sure that patients and their families do as well.”

——————————
By: Daniel Chang and Holly K. Hacker
Title: FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
Sourced From: kffhealthnews.org/news/article/fda-recall-abbott-heart-pumps-heartmate-deaths-injuries/
Published Date: Tue, 16 Apr 2024 18:20:00 +0000

Did you miss our previous article…
https://www.biloxinewsevents.com/conservative-justices-stir-trouble-for-republican-politicians-on-abortion/

Kaiser Health News

Readers Embrace ‘Going It Alone’ Series on Aging and Chastise Makers of Pulse Oximeters

Published

on

kffhealthnews.org – – 2024-11-22 04:00:00

SUMMARY: Letters to the Editor discuss various healthcare concerns. Gail Daniels shares her struggles caring for a mother with dementia, while Shava Nerad reflects on the challenges faced by those without family support. Gloria Rankin suggests using pen pals to combat social isolation. Zoe Joyner Danielson recalls racial bias in pulse oximeter development, while Suzann Lebda questions fluoride’s impact on dental health. Readers also address issues like Medicare Advantage, high drug costs for seniors, and the financial burden of prepaying for baby deliveries. Liviu Steier advocates for fluorescence in dental care, emphasizing its diagnostic benefits.

Read the full article

The post Readers Embrace ‘Going It Alone’ Series on Aging and Chastise Makers of Pulse Oximeters appeared first on kffhealthnews.org

Continue Reading

Kaiser Health News

Georgians With Disabilities Are Still Being Institutionalized, Despite Federal Oversight

Published

on

kffhealthnews.org – Sam Whitehead – 2024-11-22 04:00:00

SUMMARY: Lloyd Mills, a 32-year-old with autism, cerebral palsy, and kidney disease, has faced prolonged hospitalization due to inadequate community support in Georgia. After being admitted to Grady Memorial Hospital for mental health issues, Mills waited over eight months for appropriate housing, highlighting the systemic failures of a state still grappling with the consequences of a 2010 Department of Justice lawsuit regarding care for people with developmental disabilities. Despite significant investments and improvements in services, challenges like workforce shortages and inadequate funding persist, often leaving individuals like Mills in hospitals, impacting their mental and physical well-being.

Read the full article

The post Georgians With Disabilities Are Still Being Institutionalized, Despite Federal Oversight appeared first on kffhealthnews.org

Continue Reading

Kaiser Health News

TV’s Dr. Oz Invested in Businesses Regulated by Agency Trump Wants Him To Lead

Published

on

kffhealthnews.org – Darius Tahir – 2024-11-21 18:01:00

SUMMARY: President-elect Donald Trump nominated celebrity doctor Mehmet Oz to head the Centers for Medicare & Medicaid Services (CMS). Oz, known for his investments in healthcare, tech, and food companies, holds significant stakes in UnitedHealth Group, CVS Health, Amazon, and other companies involved in health insurance and pharmaceuticals, raising potential conflicts of interest. His financial ties include hospital stocks and pharmaceutical investments. Oz has expressed support for Medicare Advantage and criticized the food and healthcare industries. Critics question whether Oz can separate his financial interests from his role, particularly with companies doing business with the federal government.

Read the full article

The post TV’s Dr. Oz Invested in Businesses Regulated by Agency Trump Wants Him To Lead appeared first on kffhealthnews.org

Continue Reading

Trending