Devices

Draeger Anesthesia Workstation Correction Expanded

Draeger has expanded a 10/2024 device correction (Class 1 recall) to include additional Atlan A350 and A350XL anesthesia workstations used in operating rooms and other procedural settings. The devices are used to deliver inhaled anesthesia and provide both automatic and manual ventilation for adult, pediatric, and neonatal patients.

According to an FDA notice, the affected devices contain a manufacturing defect that may cause the piston ventilator to fail either before use or during a procedure. If the failure occurs while the device is in standby mode or undergoing system testing, mechanical ventilation may not start. If the malfunction occurs during active use, the workstation displays a "Ventilator error!!!" message and mechanical ventilation may stop.

Although ventilation support can continue through manual ventilation or spontaneous breathing modes, clinicians may need to manually ventilate patients to prevent injury, the agency says. It warns that ventilation failure could result in serious adverse health consequences, including hypoxia, loss of lung recruitment, bradycardia, cardiac arrest, and death.

Last month, Draeger notified customers of the issue and advised facilities that the devices may continue to be used under constant supervision until corrective actions are completed. The company plans to replace the ventilator motor assembly in affected anesthesia workstations.

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