Tag: Ventricular assist device
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…
VAD implant requirement reinstated
Editor's Note The Joint Commission, on April 26, announced that the Centers for Medicare & Medicaid Services (CMS) requirement to count the volume of ventricular assist device (VAD) implants by surgeons will be reinstated on May 11. CMS stopped this requirement during the COVID-19 public health emergency.
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