Drugs

Medline Issues Correction for Procedure Kits

Medline Industries is recalling (Class 1 device correction) certain lots of its medical procedure kits that include recalled Medtronic Aortic Root Cannulas due to a potential safety risk that could result in serious adverse health outcomes, including stroke or death.

The cannulas, a critical component used during heart surgeries involving a cardiopulmonary bypass machine, were found to potentially contain excess material in the male luer — the connector that links to other devices, a recall notice says. This defect could disrupt blood flow or embolize material into the bloodstream, posing serious risks such as neurological deficits, procedural delays, or fatal complications.

The notice says that while no serious injuries or deaths have been reported to date, Medline is urging healthcare providers not to use the cannula included in the affected kits. The company is distributing correction labels to affix to the kits, alerting users to discard the Medtronic Aortic Root Cannula and instead use an equivalent product from another manufacturer.

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