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

This story also ran on CBS News. It can be republished for free. 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 patients 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. In an emailed response, Abbott said it had communicated the risk to customers this year.

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 doesnt 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 cant 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 nearly 14,000 devices. 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 manufacturers instruction manual. (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 Abbotts website.)

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 FDAs 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 patients 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. Rates of outflow obstruction are low, Abbott spokesperson Justin Paquette said in an email, adding that patients whose devices are functioning normally have no reason for concern. Email Sign-Up

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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.

Mondays 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 devices 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. More from This InvestigationWhen Medical Devices Malfunction

Americans trust the FDA to make sure medical devices are safe and to act swiftly if problems arise. But a yearlong investigation by KFF Health News revealed that a series of FDA-cleared products, both implanted in the human body and used to treat chronic diseases, have been suspected of contributing to thousands of injuries and patient deaths.Read More

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. Its not a perfect option no pump ever is but this is as good as its ever been.

Its 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 werent 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.

Were going to expect to have some data saying, Hey we created this fix, and this fix works, and it doesnt cause a new problem. Thats what I want to know, he said Theres 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.

[Update: This article was updated at 5:20 p.m. ET on April 16, 2024, with a response from Abbott Laboratories, which it provided after publication.] Daniel Chang: dchang@kff.org, @dchangmiami

Holly K. Hacker: HHacker@kff.org, @hollyhacker Related Topics Health Industry FDA Investigation Medical Devices Patient Safety When Medical Devices Malfunction Contact Us Submit a Story Tip

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Iraqi prime minister’s coalition wins parliamentary elections

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Iraqi prime minister's coalition wins parliamentary elections

A coalition led by Iraq’s prime minister has won the country’s parliamentary elections, Baghdad’s electoral commission has said.

Mohammed Shia al Sudani, who has led the Middle Eastern nation since 2022, was seeking a second term in power.

During the campaign, he attempted to portray himself as a leader who could bring stability to Iraq after years of crisis.

But many young voters saw the vote as a means for the country’s elite to divide the spoils of the country’s oil wealth among themselves.

Iraqi Prime Minister Mohammed Shia al Sudani. Pic: AP
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Iraqi Prime Minister Mohammed Shia al Sudani. Pic: AP

The coalition Mr Sudani leads received 1.32 million votes. Turnout was 56.11%, the electoral commission said on Wednesday.

Supporters of the prime minister held celebrations in Baghdad shortly after the announcement of the preliminary results.

Hamid Hemid hailed his victory, saying: “He is the number one in Iraq, and not only Baghdad.”

However, the result does not mean Mr Sudani will necessarily remain the prime minister.

No single bloc of parties won enough seats to form the government themselves, meaning a coalition deal will have to be struck.

In several past elections in Iraq, the group winning the most seats has not been able to impose its preferred candidate.

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After the last elections, which took place in 2021, a party led by influential Shia cleric Muqtada al Sadr won the largest number of seats but withdrew from negotiations to form a new government.

Speaking in a televised speech following the announcement of the initial results, Mr Sudani said: “The voter turnout is clear evidence of another success, reflected in the restoration of confidence in the political system.”

Iraq has been wrecked by violence and dominated by powerful Iran-backed militias since it was invaded by a US-led coalition in 2003.

Earlier this year, Mr Sudani travelled to London to negotiate a series of deals on the economy and diplomacy.

Speaking to Sky News during his visit, he insisted he was in control of Iraq despite the presence of armed groups using its territory to attack Israel.

He said: “We’re not embarrassed in any way, we carry out our duties to enforce the law, to maintain security and stability in Iraq and reject all means of violence. We won’t allow any side to dictate the decision between peace and war.”

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Economy grew by 0.1% in third quarter, official figures show

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Economy grew by 0.1% in third quarter, official figures show

The UK’s economic slowdown gathered further momentum during the third quarter of the year with growth of just 0.1%, according to an early official estimate that makes horrific reading for the chancellor.

The Office for National Statistics (ONS) reported a surprise contraction for economic output during September of -0.1% – with some of the downwards pressure being applied by the cyber attack disruption to production at Jaguar Land Rover.

The figures for July-September followed on the back of a 0.3% growth performance over the previous three months and the 0.7% expansion achieved between January and March.

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Growth ‘slightly worse than expected’

The encouraging start to 2025 was soon followed by the worst of Donald Trump’s trade war salvoes and the implementation of budget measures that placed employers on the hook for £25bn of extra taxes.

Economists have blamed those factors since for pushing up inflation and harming investment and employment.

ONS director of economic statistics, Liz McKeown, said: “Growth slowed further in the third quarter of the year with both services and construction weaker than in the previous period. There was also a further contraction in production.

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“Across the quarter as a whole, manufacturing drove the weakness in production. There was a particularly marked fall in car production in September, reflecting the impact of a cyber incident, as well as a decline in the often-erratic pharmaceutical industry.

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What next for the UK economy?

“Services were the main contributor to growth in the latest quarter, with business rental and leasing, live events and retail performing well, partially offset by falls in R&D [research and development] and hair and beauty salons.”

When measured by per head of population- a preferred measure of living standards – zero growth was registered during the third quarter.

The weaker-than-expected figures will add fuel to expectations that the Bank of England can cut interest rates at its December meeting after November’s hold.

The vast majority of financial market participants now expect a reduction to 3.75% from 4% on 18 December.

Data earlier this week showed the UK’s unemployment rate at 5% – up from 4.1% when Labour came to power with a number one priority of growing the economy.

Since then, the government’s handling of the economy has centred on its stewardship of the public finances.

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Chancellor questioned by Sky News

The chancellor was accused by business groups of harming private sector investment and employment through hikes to minimum wage levels and employer national insurance contributions.

The Bank has backed the assertion that hiring and staff retention has been hit as a result of those extra costs.

There is also evidence that rising employment costs have been passed on to consumers and contributed to the UK’s stubbornly high rate of inflation of 3.8% – a figure that is now expected to ease considerably in the coming months.

Rachel Reeves has blamed other factors – such as Brexit and the US trade war – for weighing on the economy, leaving her facing a similar black hole to the one she says she inherited from the Conservatives.

Her second budget is due on 26 November.

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She said of the latest economic data: “We had the fastest-growing economy in the G7 in the first half of the year, but there’s more to do to build an economy that works for working people.

“At my budget later this month, I will take the fair decisions to build a strong economy that helps us to continue to cut waiting lists, cut the national debt and cut the cost of living.”

Shadow chancellor Sir Mel Stride responded: “Today’s ONS figures show the economy shrank in the latest month, under a Prime Minister and Chancellor who are in office but not in power.”

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Scottish government yet to pay up after losing legal battle over definition of a woman

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Scottish government yet to pay up after losing legal battle over definition of a woman

The Scottish government and For Women Scotland’s long-running legal battle over the definition of a woman is yet to come to a close.

For Women Scotland (FWS) won the case in April when the country’s highest court ruled “woman” and “sex” in the Equality Act 2010 refers to “a biological woman and biological sex”.

The Scottish government was ordered to pay a portion of the campaign group’s legal costs.

FWS told Sky News the bill of costs for the Supreme Court element of the case was more than £270,000, however various parts have reportedly been disputed by the Scottish government.

That has now been submitted to the court for determination and a decision is awaited.

Pic: PA
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Pic: PA

The Outer and Inner House element of the case at the Court of Session in Edinburgh was said to be more than £150,000.

Trina Budge, co-director of FWS, said the group is also due an uplift – a small percentage of the final expenses awarded.

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Ms Budge claimed Scottish ministers are yet to enter into any negotiations on settlement and a date has been set in January for a hearing before the Auditor of the Court of Session to confirm the amount the government will have to pay.

Ms Budge said: “The delay always suits the paying party but I think it’s quite unusual to decline to enter into any discussions at all.

“It’s highly likely this is a deliberate tactic in the hope of starving us of funds to prevent us continuing our latest case on the lawfulness of housing male prisoners on the female estate.

“However, it should come as no surprise to the government that we have massive support and we will, of course, be continuing regardless of any sharp practices.”

Susan Smith and Marion Calder, co-directors of For Women Scotland, outside the Supreme Court in London in April. Pic: PA
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Susan Smith and Marion Calder, co-directors of For Women Scotland, outside the Supreme Court in London in April. Pic: PA

It is understood the bill of costs for the Supreme Court case was lodged by FWS in August, while the expenses linked to the Court of Session action was submitted in September.

Figures revealed by a recent Freedom of Information (FOI) request show the Scottish government has spent at least £374,000 on the case.

Final costs are yet to be confirmed but will be published once complete.

A Scottish government spokesperson said: “There is an established process to be undertaken to agree the final costs for a legal case and these will be calculated and published in due course.”

In August, FWS lodged fresh action at the Court of Session.

The group claimed Holyrood’s guidance on transgender pupils in schools and the Scottish Prison Service’s (SPS) policy on the management of transgender people in custody were both in “clear breach of the law” and “inconsistent” with the Supreme Court judgment.

The following month, the Scottish government issued updated guidance which said schools across the nation must provide separate toilets for boys and girls on the basis of biological sex.

If possible, schools can also provide gender neutral toilets for transgender students.

However, court proceedings continue over transgender prisoners.

Current SPS guidance allows for a transgender woman to be admitted into the female estate if the inmate does not meet the violence against women and girls criteria, and there is no other basis “to suppose” they could pose an “unacceptable risk of harm” to those also housed there.

First Minister John Swinney and Justice Secretary Angela Constance have both dodged questions on the case, citing it would be inappropriate to comment on live court proceedings.

Justice Secretary Angela Constance and First Minister John Swinney. Pic: PA
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Justice Secretary Angela Constance and First Minister John Swinney. Pic: PA

On Tuesday, Ms Constance was accused by former Scottish Tory leader Douglas Ross of “misleading” Holyrood, saying she could give full answers under contempt of court legislation.

Scottish Tory MSP Tess White, the party’s equalities spokesperson, added she was “spine-chillingly concerned” of a repeat of the Isla Bryson case.

The case of Isla Bryson sparked a public outcry after the double rapist was sent to a women-only prison. Pic: PA
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The case of Isla Bryson sparked a public outcry after the double rapist was sent to a women-only prison. Pic: PA

Bryson, a transgender woman born Adam Graham, was initially sent to a women-only prison despite being convicted of raping two women.

The offender was later transferred to the male estate following a public outcry.

Speaking to Sky News, Ms White said: “John Swinney was quick to waste taxpayers’ money fighting a case which confirmed what the vast majority of the public knew beforehand: a woman is an adult human female.”

The MSP for North East Scotland urged the SNP administration to “pay up and finally respect the clear judgment from the Supreme Court”.

A Scottish government spokesperson said: “It is the Scottish government’s long-held position that it is inappropriate for Scottish ministers to comment on live litigation.

“In all cases, we have an obligation to uphold the independence of the judiciary. We do not want the government to ever be seen as interfering in the work of the independent courts.”

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