Devices

Class 1 Correction Recall on Electrodes Updated

FDA has updated a Class 1 recall (correction) of Megadyne Medical Products’ Mega Soft patient return electrode models. An agency notice says the recall was to update the instructions for use and product labeling to restrict the use of the device to patients aged 12 years and older.

“Megadyne has received reports of patient burn injuries, including third-degree burns requiring intervention,” an earlier notice said. “There have been 99 reported injuries. There have been no reports of death.”

Since that notification, the company says it has continued to “monitor device performance through post market surveillance, investigated every event reported and evaluated potential root cause of these events. Megadyne recently received a report of pediatric use that included a serious 3rd-degree patient burn.” The update reiterates that the devices should not be used for patients under the age of 12 years.

The patient return electrode is described as a medical device for surgeries involving the use of electrosurgical instruments. It reportedly is designed to ensure patient safety by providing a safe return path for the electrical current used in the procedures. The recall covers 9,428 units that were distributed between 10/1/2021 and 12/4/2023.

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