Devices

Philips Respironics Recalls Trilogy Evo Ventilators

Philips Respironics has recalled certain Trilogy Evo ventilators due to potential health risks caused by a polyester-based polyurethane sound abatement foam that a supplier incorrectly used in the muffler assembly of the affected devices. The issue was identified during lab testing, according to a recall notice. The recalled ventilators were distributed to customers in the U.S. and Korea.

The notice warns that the foam may break down and potentially enter the device’s air pathway. “If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device,” it says.

The notice says Trilogy 100 and 200 ventilators were previously recalled 6/2021 due to the same foam risk. Other Trilogy models are not affected by the issue and are not being recalled — Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal.

FDA last year inspected Philips Respironics and issued a 29-page Form FDA-483 based on a Class 1 recall follow-up (see story). The inspection was initiated to assess compliance with regulatory requirements and to investigate concerns about the devices’ sound abatement foam.

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