Devices

Baxter Class 1 Recall of Life2000 Ventilator

Baxter Healthcare is recalling (Class 1) its Life2000 ventilator to update the use instructions after finding that the device may fail to issue a “low gas pressure alarm” if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not connected to the ventilator and turned on before starting therapy. The company is developing a software update to address the issue and will contact affected customers once it is available, a recall notice says.

“The use of affected product may cause serious adverse health consequences, including shortness of breath, a drop in oxygen levels (desaturation), and death,” the notice says. To date, the company says there has been one reported injury.

The device is intended to provide continuous or intermittent breathing (ventilatory) support for people who require mechanical ventilation assistance. It provides positive pressure ventilation through a tube inserted into the trachea (endotracheal) or through a mask placed over the face.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome