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FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries

KHN

APRIL 16, 2024

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. ” said Sanket Dhruva , a cardiologist and an expert in medical device safety and regulation at the University of California-San Francisco.

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

KHN

DECEMBER 19, 2023

. “To me this is a safety signal and it’s hard to know if the FDA is working on something to address it,” said Kinard, founder of Device Events , a company that makes FDA device data more user-friendly for hospitals, law firms, investors, and others. “The FDA may be missing some signals,” he said.

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FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries

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

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