Devices

Olympus Recalls High-Flow Insufflation Units

Olympus has recalled (Class 1) its high-flow insufflation units, warning that continued use of the devices could cause serious injury or death. An agency notice says a software algorithm in the devices requires correction to address a potential issue that could result in overpressure events during use. Because no corrective update or repair solution is available, the company opted to remove the products from the market entirely, it says, adding the action affects discontinued models UHI, UHI-2 and UHI-3.

The devices are used during laparoscopic procedures to insufflate the abdominal cavity, providing space for visualization and surgical intervention. The systems also offer automatic suction and smoke evacuation.

FDA warns that overpressure may lead to complications including air embolism, cardiac arrhythmias such as bradycardia or asystole, cardiac arrest, pneumothorax, hypoxia, kidney or urinary complications, subcutaneous emphysema, procedural delays, more complex interventions, and potentially 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