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.
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 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 devic …
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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.
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 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 devic …nnDiscussion:nn” ai_name=”RocketNews AI: ” start_sentence=”Can I tell you more about this article?” text_input_placeholder=”Type ‘Yes'”]