Devices

Medtronic Recalls Cerebrospinal Fluid Drain

Medtronic Neurology has recalled (Class 1) its Duet External Drainage and Monitoring System, which is used to drain cerebrospinal fluid (CSF) to reduce intracranial pressure and CSF volume, due to the potential for catheter disconnection from patient line stopcock connectors. An FDA recall notice notes that the cause of the issue is under investigation by the company.

Medtronic describes the device as using gravity to drain CSF from a patient’s ventricles or lumbar space to an external drainage receptacle. “The Duet’s catheter is surgically attached to the patient before it is attached to the drainage system,” it says. Through an opening in the patient’s skull or lumbar region, a catheter is inserted into the ventricle or the lumbar subarachnoid space, and then it is attached to the drainage system.

Medtronic is advising healthcare professionals to immediately identify and quarantine any unused products and make arrangements to return all unused and non-expired products 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