Miami, Florida – A recent FDA recall has raised concerns about the safety and efficacy of two heart devices linked to numerous injuries and deaths. The FDA announced on Monday that the HeartMate II and HeartMate 3, produced by Thoratec Corp., a subsidiary of Abbott Laboratories, are the subject of the agency’s most serious recall.
Despite the HeartMate 3 being considered the safest mechanical heart pump of its kind, reports show over 4,500 incidents where the device may have contributed to patient deaths. The delayed action on the recall has prompted questions from safety advocates about the reporting process for issues with approved medical devices.
Surgeons first noticed problems with the HeartMate devices years ago, leading to concerns about the lack of transparency in informing the public. The recall affects nearly 14,000 devices implanted in patients with end-stage heart failure waiting for a transplant or in need of a permanent solution.
A study published in 2022 reported a 3% incidence rate of obstruction with the devices, with higher rates in patients the longer they had the implant. The FDA recall notice issued additional guidance for physicians to diagnose blockages and take appropriate action if needed.
The FDA’s alert comes on the heels of a previous Class 1 recall earlier in the year for a separate issue where the HeartMate 3 could unintentionally start and stop due to a communication system malfunction. Abbott has issued urgent letters to hospitals addressing these concerns and is working on a design solution to prevent further issues.
If the devices were to be removed from the market, patients with end-stage heart failure could be left without viable options, raising serious concerns among medical professionals. Transparency from Abbott regarding their efforts to address the problems with the HeartMate devices is crucial for physicians to have informed discussions with their patients.
The lack of mandatory reporting of adverse events by physicians to federal regulators has also raised questions about communication within the medical community. With only device manufacturers, importers, and hospitals required by law to report incidents to the FDA, the need for improved communication and transparency is evident.
As the investigation into the safety of the HeartMate devices continues, patients, medical professionals, and regulatory agencies are closely monitoring the situation for updates on potential solutions and next steps to ensure patient safety.