Devices

Maquet Servo Ventilators in Class 1 Recall

Maquet Critical Care AB, a subsidiary of Getinge, is recalling (Class 1 device correction) its Servo Ventilator Systems to update their use instructions due to the risk of inaccurate compliance measurement leading to improper tidal volume delivery in neonatal patients. The devices can be used with several different patient circuits and active humidifiers.

“Before being used on a patient, the ventilator must pass a safety check that measures leakage, compliance, and resistance in the circuit,” a recall notice says. “Some humidifiers may not pass the standard leak test due to their design, even if there’s no actual leak. To address this, there is an optional configuration for the ventilator with an ‘extended leakage test’ in the ventilator’s Service & Settings menu.” This extended test should only be used with humidifiers that cannot pass the standard leak test, the notice says, adding that if a hospital uses multiple humidifier types, there’s a risk that the ventilator could be set to the wrong test for the humidifier being used.

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