Devices

Alert on VasoView Vessel Harvesting Devices

FDA has issued an alert about safety concerns with the use of Getinge/Maquet’s VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems, and a supply concern for EVH devices. In September, the company sent customers an Urgent Medical Device Removal notice telling them to not use the devices because there is a risk that silicone may detach from the jaws of the harvesting tool during use, resulting in the device becoming non-functional and/or silicone debris entering the patient. “Detachment of silicone into the patient can lead to an EVH procedural delay and/or conversion of the EVH procedure to a more invasive open vessel harvest procedure,” the alert says.

The company says it received 18 complaints about the devices and silicone detaching from the jaws of the harvesting tool during use. “There were 17 reports of serious injury due to silicone debris being introduced to the patients including three instances where this debris was unable to be removed,” the alert says.

Because the removal of VasoView HemoPro 1.5 from the market may interrupt the supply of EVH devices, FDA says it has updated the medical device shortage list to include EVH devices.

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

Read more

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