FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries

The FDA has issued a Class 1 recall for the HeartMate II and HeartMate 3 heart devices, linking them to hundreds of injuries and at least 14 deaths. The recall comes years after issues were first noticed by surgeons. Abbott Laboratories, the manufacturer, has communicated the risk to customers. The devices are not being removed from the market, affecting nearly 14,000 patients. The devices can cause blockages that reduce their effectiveness, requiring monitoring or surgery. Some safety advocates question the delayed action and lack of transparency. Patients and doctors are concerned about the lack of information and potential consequences of the recall.

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