The FDA issued a safety alert after users reported nitric oxide dose fluctuations, potentially leading to hypoxemia or increased pulmonary artery pressure.
NOxBOX Ltd, a subsidiary of Linde Gas & Equipment Inc, is correcting NOxBOXi Nitric Oxide Delivery System due to safety considerations associated with using this nitric oxide delivery system together with the Bunnell LifePulse High Frequency Jet Ventilator and potentially other conventional ventilators, according to a medical device safety alert from the US Food and Drug Administration.
Customers reported fluctuations in the monitored nitric oxide value (greater than ±20% of the set dose) when the NOxBOXi system is used with specific settings on the Bunnel LifePulse. This issue may cause an interruption to therapy, leading to a drop in blood oxygen levels or increased pressure in the artery that carries oxygen from the heart to the lungs.
The use of affected product may cause serious adverse health consequences, including a drop in blood oxygen levels, increased artery pressure, and death. As of Aug 28, 2025, NOxBOX Ltd has reported three serious injuries and no deaths associated with this issue.
The NOxBOXi Nitric Oxide Delivery System is intended for the delivery and monitoring of a constant concentration of nitric oxide as well as monitoring of nitrogen dioxide and oxygen in the inspiratory ventilator lines of a patient undergoing inhaled nitric oxide therapy.
ID 205612229 © Sudok1 | Dreamstime.com
