The company faces more than 2,000 lawsuits alleging it sold defective knee and hip implants.
Category: When Medical Devices Malfunction
From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA
The story of MitraClip, a device Dr. Oz helped invent to treat faulty heart valves, is a cautionary tale about the science, business, and regulation of medical technology.
FDA Said It Never Inspected Dental Lab That Made Controversial AGGA Device
Johns Dental Laboratories stopped making the Anterior Growth Guidance Appliance last year after a KFF Health News-CBS News investigation into allegations of patient harm. The company had “never” reported any complaints about its products to the FDA, according to the agency.
FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
Some pumps used in end-stage heart failure caused a buildup of biological material that blocks blood flow from the device to the heart’s aorta. The FDA’s recall affects nearly 14,000 devices.
FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
Some pumps used in end-stage heart failure caused a buildup of biological material that blocks blood flow from the device to the heart’s aorta. The FDA’s recall affects nearly 14,000 devices.
