April 17, 2024

FDA Class 1 recall renews concern about historically problematic heart pumps

The US Food & Drug Administration (FDA) announced a Class 1 recall on Monday for Abbott/Thoratec Corp.’s HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due due to biological material buildup obstructing the devices.

According to an April 16 CBS News report, surgeons first noticed problems with the LVAS devices—commonly used to help the heart pump blood in end-stage heart failure—years ago, yet the devices are not being removed from the market. “The delayed action raises questions for some safety advocates about how and when issues with approved medical devices should be reported,” that article reads, noting that the devices have been associated with thousands of reports of patient injuries and deaths.

According to the recall notice, the manufacturer notified affected customers in a February 29 letter advising paying attention to flow alarms, “as this is the first symptom of significant outflow obstruction.” The manufacturer also reportedly provided guidance on diagnosing unresolved low flow associated with outflow graft obstruction.”

This Class 1 recall—indicating risk of serious injury or death—affects nearly 14,000 devices, CBS reports, noting that Monday's alert is the second Class 1 recall of a HeartMate device this year.

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