The FDA has issued a Class 1 recall for the HeartMate II and III devices, manufactured by Thoratec Corp., due to hundreds of injuries and at least 14 deaths. The recall comes years after surgeons first noticed problems. The devices help the heart pump blood and are used in patients with end-stage heart failure. Abbott Laboratories did not respond to requests for comment. The recall involves addressing obstruction buildup in the devices. Transparency and communication between physicians and regulators are being questioned. The HeartMate 3 is the only medical option for many patients with end-stage heart failure and who do not qualify for a transplant.
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FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
