Kaiser Health News
FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
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.
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
As California Taps Pandemic Stockpile for Bird Flu, Officials Keep Close Eye on Spending
SUMMARY: California is using state and federal stockpiles to provide up to 10,000 farmworkers with safety gear as the state reports 21 human cases of bird flu. The state began distributing protective equipment in May and has confirmed bird flu at over 270 dairies. Drawing lessons from the COVID-19 pandemic, California is improving emergency responses and maintaining a stockpile that includes millions of face masks. However, due to financial constraints, funding for disaster supplies has been cut, and some preparedness programs were reduced or eliminated. A ballot measure to increase pandemic preparedness funding failed after its key financial supporter was convicted.
The post As California Taps Pandemic Stockpile for Bird Flu, Officials Keep Close Eye on Spending appeared first on kffhealthnews.org
Kaiser Health News
After Congress Ended Extra Cash Aid for Families, Communities Tackle Child Poverty Alone
SUMMARY: Dr. Mona Hanna, a pediatrician in Flint, Michigan, is championing the Rx Kids program, a pioneering cash aid initiative that provides $1,500 mid-pregnancy and $500 monthly for a child’s first year to Flint families. Since its January launch, nearly all babies born in Flint are enrolled, aiding parents with essential needs like diapers and food. While Rx Kids aims to reduce poverty and inspire lawmakers and donors, challenges remain for expansion in underserved regions like Michigan’s Upper Peninsula, where substantial private funding is needed. Ongoing efforts seek to raise awareness and secure resources for this impactful program.
The post After Congress Ended Extra Cash Aid for Families, Communities Tackle Child Poverty Alone appeared first on kffhealthnews.org
Kaiser Health News
California Dengue Cases Prompt Swift Response From Public Health Officials
SUMMARY: Jason Farned and his team at the San Gabriel Valley Mosquito and Vector Control District have been preparing for dengue’s arrival, with the virus now detected in California. The spread of Aedes mosquitoes, capable of transmitting dengue, has been fueled by climate change and international trade. In 2023, California saw 13 locally acquired cases, prompting efforts like surveillance, pesticide applications, and public education. Authorities are also exploring techniques like sterile mosquito releases to reduce populations. Public cooperation is key, as Aedes mosquitoes are now established in 24 counties, and local outbreaks pose a growing threat to public health.
The post California Dengue Cases Prompt Swift Response From Public Health Officials appeared first on kffhealthnews.org
-
News from the South - North Carolina News Feed7 days ago
Arrest made in I-40 Shootings: 7 cars have been shot, 1 woman injured
-
News from the South - Alabama News Feed3 days ago
Crash involving MPD vehicle
-
Local News5 days ago
84% of Mississippi 3rd graders pass reading assessment for 2023-24 school year
-
Mississippi Today6 days ago
On this day in 1955
-
News from the South - Missouri News Feed3 days ago
Veterans honored across Missouri, Illinois for Veterans day
-
News from the South - Georgia News Feed3 days ago
Who will serve in Trump’s cabinet? | FOX 5 News
-
News from the South - Tennessee News Feed3 days ago
Afternoon Weather (11/11): Dry afternoon ahead
-
Mississippi News Video3 days ago
The War Memorial Building in Jackson