Devices

Class 1 Recall of Medtronic HVAD Pump Kit

Medtronic is recalling (Class 1) its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit because the device may fail to initially start, restart, or have a delay in restarting after the pump was stopped. Such delays or failures to start or restart have occurred during pre-implant testing, during the implant, or in a variety of post-implant situations, a recall notice says. A delay or start failure could cause serious patient harm including a heart attack, worsening heart failure, the need for additional procedures and hospitalizations, or death, it says. To date, 29 complaints about the issue have been reported, including two deaths, 19 serious injuries and eight cases of patients who had a life-threatening event but recovered without long term effects, it adds.

The HVAD Pump Implant Kit is part of the HeartWare HVAD System, which is used to help the heart continue to pump blood to the rest of the body. It is used 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 where new transplants are not planned, the recall notice says.

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