Devices

Abbott Recalls HeartMate System Monitor

Abbott Medical is recalling (Class 1) its HeartMate System Monitor due to “atypical behavior of the System Monitor screen.” The agency notes that the recall is considered a device correction and is not a market withdrawal.

The screen issues include screen freezing, overlapping buttons or screens, unresponsive buttons, distorted text or graphics, and wrong or missing information on the display, according to a recall notice. “These issues can cause a clinician user to inadvertently change pump settings or press the pump stop button.”

The notice warns that using affected products may cause serious adverse events, including decrease in blood pressure and inadequate blood flow (hemodynamic compromise) caused by a pump stop, which can lead to stroke, irreversible brain damage, heart or organ failure, and death. To date, there have been 14 reported injuries and no reports of death.

The monitor is part of the HeartMate Left Ventricular Assist System, which is used to help the heart pump blood when it is not able to do so effectively on its own.

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