Devices

Cook Medical Recalls CrossCath Catheters

Cook Medical has recalled (Class 1) its CrossCath Support Catheters due to a manufacturing error which may cause the marker bands to dislodge. A recall notice says that the company has identified that an error occurred during manufacturing which may cause the radiopaque marker bands to be too loose or too tight on certain devices. “Marker bands that are too loose can dislodge from their original position and marker bands that are too tight can cause buckling,” it says.

The recall notice says that using the affected product can “cause ׅincreased procedural time to obtain a replacement, increased procedural time due to difficult advancement of the catheter through a lesion, additional intervention to remove a catheter that becomes stuck within a lesion, additional intervention to remove separated marker band(s). There is also the potential that the separated marker band cannot be retrieved, and it can cause permanent impairment like loss of limb; or the fragment can obstruct blood flow (embolize), resulting in life-threatening harm (e.g., stroke), or death.”

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