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A company took its heart pump off the market. ProPublica knew that wasn’t the full story.

December 7, 2022

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Photo from Pexels user Anna Shvets

Alicia Warren has heart failure, and she’s raising two daughters alone.

She started experiencing symptoms when she was just 22 — right after she had her first daughter.

As Warren got older, her health deteriorated. When she was 40, doctors said she only had a month left to live — unless she got a heart pump device implanted in her chest.

She did.

But three years later, she found out her model of heart pump was taken off the market. Her doctor didn’t tell her; she read it on Facebook.

“I’m sure if this was true, my doctors would’ve told me. They should’ve been straightforward with us about what was going on,” Warren told ProPublica. “I haven’t gotten a letter to this day from anybody saying anything about that recall.”

Medtronic, the company that purchased heart-pump maker Heartware in 2016, said it took the device off the market in 2021 because a competing device was safer.

But ProPublica reporter Neil Bedi knew that wasn’t the full story.

By digging through records, Bedi realized that the Federal Drug Administration had identified a problem: the heart pump wasn’t meeting key federal standards. In 2014, the FDA issued a warning letter to Heartware, the company that owned the device, saying the device was faulty. The agency told Heartware it had 15 days to correct the device’s problems — or they’d face regulatory action.

After the 15-day deadline passed, the agency didn’t do anything else. But patients continued to have the device implanted in their chests for seven more years.

And the heart pump’s faults may have killed people, according to a ProPublica data analysis: “by the end of 2020, the FDA had received more than 3,000 reports of deaths related to the HeartWare device.”

In 2016, another company, Medtronic, acquired HeartWare. Even after Medtronic pulled the Heartware heart pump off the market, the FDA still took no action — despite having a yearslong paper trail detailing the device’s faults.

Anonymized government reports tell the harrowing stories of patients who died over the device’s malfunctions: a teenager who died after vomiting blood in the middle of the night. A father of four who died surrounded by his children, who attempted to resuscitate him when his pump suddenly stopped working.

Bedi wasn’t handed this story through a confidential tip or leak. He stumbled across it in a government database.

“This story started in the records, in government records that had been there the whole time. And I just happened to take a look at them,” he told The Reynolds Center.

The idea for the story came from an unlikely source: an ad for a medical device symposium in Florida.

“It got me thinking ‘what is the device that hurts most people that comes out of Florida?’ Just a simple question,” Bedi said.

He opened the FDA’s database to start doing data analysis, looking for devices with the most deaths and injuries.

Then he found Medtronic’s heart pump.

Even though Medtronic voluntarily took the device off the market only a few months after he started working on the story, that did not stop Bedi from continuing his investigation and publishing the story.

In March this year, Congress opened an investigation into how the FDA handled its role in regulating the high-risk heart pump.

Read the first in a series of investigative articles on the subject here.

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