Devices

Abbott Recalls HeartMate Power Units

Abbott is recalling (Class 1) its HeartMate Mobile Power Unit (MPU) because of instances where the device experiences a sudden power loss. A recall notice says the company has received reports in which the MPU experienced sudden, unexpected performance issues such as not turning on, unprompted shutdown, or suddenly turning off and restarting, with the system controller indicating a “Yellow Wrench” alarm or “No External Power” alarm.

“Abbott has identified that these issues are linked to an electrical component used to manufacture certain MPUs distributed between 4/2024 and 2/2025,” the notice says. “Replacement of impacted MPU devices that have experienced power issues will begin immediately; replacement of impacted MPU devices not currently experiencing power issues will begin in June 2025 or earlier.”

If an impacted MPU experiences a loss of power, the backup battery can support the pump for up to 15 minutes, the notice says. Abbott notes that if the 14V rechargeable batteries are not connected to the system controller within 15 minutes, the pump will lose power and stop, and this could lead to serious adverse health consequences such as hemodynamic compromise, thromboembolism, or death.

The MPU is an accessory of the HeartMate Left Ventricular Assist System, an implantable pump diverting blood from the weakened left ventricle of the heart and pumping it to the aorta, according to the company.

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