Devices

Ethicon Endo-Surgery Recalls Echelon Vascular Stapler

Ethicon Endo-Surgery is recalling (Class 1 device correction) its Echelon Flex Powered Vascular Stapler to correct the product’s inadvertent lockout during surgical procedures. The device will momentarily activate but will not cut or staple tissue, a recall notice says. “Additional steps will be required to open it and remove it from tissue,” it says, adding that using an affected product may cause serious adverse health consequences, including life-threatening hemorrhage, surgical delay, and death. To date, one reported death and one serious injury have been reported.

The notice says the device is designed to prevent patient harm due to an instrument lockout. “During a lockout, the device may briefly activate but will not cut or staple tissue, requiring additional steps to release and remove it safely,” it says. “The knife does not advance far enough to cut, staples remain below the tissue contact surface, and a built-in gap between the anvil and staple cartridge face helps prevent vessel injury during clamping and unclamping.”

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