Inomax Drug Delivery System Recall: Defective Pressure Switch

A Class 1 recall has been issued for Inomax DS drug delivery systems due to a defective pressure switch that could negatively affect patients’ blood pressure.

The Inomax recall was announced on August 9 by the manufacturer, Ikaria Holdings. On Monday the FDA declared that the product defect constituted a Class 1 recall, the most serious category of medical device recall, meaning that the problem has a probability of resulting in serious injury or death to a patient.

The Inomax DS drug delivery system is used to provide patients with nitric oxide to help them breathe. However, the manufacturer says that a component in the device’s pressure switch can tear. The component detects when the drug supply should be replaced and if it is damaged then healthcare professionals may not be aware that a patient is hooked up to an empty drug supply.

Problems with the Inomax drug delivery system could cause low blood oxygen levels, low blood pressure, increased blood pressure in the pulmonary arteries, or death. However, there have been no reports of injuries or deaths related to the defect.

On July 21, the company sent a notice to customers telling them the risks of the system failure, how to detect the problem and notified them that the company intends to replace all of the affected Inomax DS drug delivery systems. It also gave instructions on what to do with a defective system while waiting for it to be repaired or replaced.

In a follow-up letter on August 9, the company announced it was recalling the systems and said that the replacement process had already begun.