Devices

Baxter Recalls Volara System Ventilator Adapter

Baxter International is recalling (Class 1) certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. To date, there have been no reported injuries associated with the issue.

“When using the Volara system in-line with a ventilator and without a nebulizer connected to the blue ventilator adapter, the handset plug is required to help ensure proper operation and ventilator gas flow,” a recall notice says. If the handset plug disconnects prior to or during therapy, it may result in reduced ventilation and oxygenation due to the ventilator leaking gas flow from the nebulizer port on the blue ventilator adapter, it says.

The recall applies to the Volara system single-patient use circuit with product codes M08473 and M08474, and the blue ventilator adapter assembly, product code M07937. The devices were distributed in the U.S. between 8/26/2022 and 12/30/2023.

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

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