Devices

Cardiosave Balloon Pump Recall Class 1: FDA

FDA says the Datascope/Maquet/Getinge 6/5 recall of Cardiosave Hybrid and Rescue intra-aortic balloon pumps for printed circuit board assembly failures is Class 1. An agency notice says the company recalled 4,586 devices distributed in the U.S. between 5/6/2012 and 5/19/2023.

The notice says the units are used in healthcare facilities in patients with acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults.

FDA says the pumps were recalled because they may shut down unexpectedly due to circuit board failures in the charging path. “If this occurs,” the notice says, “the device may lose the ability to charge batteries in one or both battery bays/slots due to electrical surge damage in the power management board charging path circuit. Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury, and death.”

The company reported 252 complaints, with no reports of injuries or death, FDA 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