Devices

Cook Medical Class 1 Recall of 2 Flexor Catheters

FDA says the Cook Medical 11/24/20 recall of Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers is Class 1. An agency notice says the two products are catheters that have a coated shaft, a valve, a dilator, and markers that show on an x-ray. The catheters reportedly help insert other medical devices used for therapy or diagnosis into the vessels, except those of the heart and brain, during surgery or other procedures.

Cook says it is recalling the two products because of an increased chance of separation at the proximal band site. If the device separates during use, the notice says, it may lead to life-threatening adverse events.

The notice says that the use of the affected product may cause serious adverse events, including longer procedure time, another procedure to take out a separate piece, blocking blood flow to vital organs, vessel injury, and bleeding. FDA says there have been 57 complaints about the device issue and 14 reports of serious injuries, with no reported deaths.

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

Read more

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