Devices

Medtronic Class 1 Recall of HeartWare HVAD Batteries

Medtronic has recalled (Class 1) one lot of batteries for its HeartWare Ventricular Assist Device (HVAD) due to welding defects that allow separation of the two cell battery packs used to power the device. The defects may cause the battery to malfunction and no longer provide power or prevent the battery from holding a charge or properly recharging, according to a recall notice, which added that as a result the battery may fail suddenly.

“If this malfunction occurs, it will trigger a power disconnect alarm on the controller screen and in the alarm log tab of the HVAD Monitor while the affected battery is still connected to the controller,” the notice says. “These alarms may temporarily resolve, but the battery will continue to fail. The use of these batteries may lead to device malfunction, death, or serious injury.” To date, Medtronic has reported one death associated with this recall, and two complaints with the affected lot.

The device is used to help the heart continue to pump blood to the rest of the body as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy in patients for whom heart transplants are not planned.

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