Devices

Getinge/Datascope/Maquet Cardiosave Recall is Class 1

FDA says the 10/27 Getinge/Datascope/Maquet recall of Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps is Class 1. An agency notice says the company recalled 4,338 devices in the U.S. manufactured between 12/2011 and the present and distributed 3/6/2012 to 10/21/2021.

The devices were recalled due to complaints of fluid leaks, the notice says. Fluid entering the unit could cause pump shutdown or the inability to initiate therapy, FDA says. There have been one death and 71 complaints reported on the issue.

The Hybrid and Rescue pumps are cardiac assist devices used with patients undergoing cardiac and non-cardiac surgery and to treat adults who have acute coronary syndrome or complications of heart failure.

The company says it plans to correct all devices in the field to include various internal and external component upgrades that will be made available in an ingress prevention update kit and installed by a company representative. Customers also are to receive redesigned display and rescue covers for the Cardiosave transport console.

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