FDA Gives React Health's VOCSN V+Pro Ventilator Removal Its Most Serious Recall Rating

The US Food and Drug Administration has identified React Health's removal of certain VOCSN V+Pro ventilators as the most serious type of recall, according to a notice the agency posted on May 21.

The notice says Ventec, doing business as React Health, has sent affected customers a letter recommending that certain VOCSN V+Pro units be removed from where they are used or sold. The FDA said the device "may cause serious injury or death if you continue to use it." Two products are listed: the V+Pro Package, catalog number PRT-01198-000, and the V+Pro Unit, catalog number PRT-01185-000. The agency links to a full list of affected devices.

An oxygen leak that testing may have missed

According to the FDA, React Health is removing the devices because of "a manufacturing process deviation that may result in an undetected oxygen leak condition." The notice says that because of a manufacturing test configuration error, certain devices may not have been evaluated under all intended high-pressure conditions during production testing.

As a result, an oxygen leak could occur that may lead to out-of-specification delivery of inspired oxygen, measured as FiO2, before or during ventilation. The FDA said delivered oxygen could fall below intended levels, and that in oxygen-enriched environments a leak could also increase fire risk. "These conditions could potentially result in serious patient injury or death," the notice says.

The agency said that as of March 4, React Health had not reported any serious injuries or deaths associated with the issue.

What customers were told

React Health sent all affected customers a letter on March 23, the FDA said. The letter asked them to immediately discontinue use of affected VOCSN V+Pro units, inspect stock, quarantine any unused affected products and remove affected devices from clinical service. Customers were told to use a non-affected ventilator for patient support and to notify any facilities, caregivers or end users to whom they had passed affected devices.

The FDA's own recommendation is to identify and stop using affected devices and to use a non-affected ventilator for patient support. US customers with questions or reports of adverse reactions or quality problems can contact React Health at 844-698-6276, the notice says.

The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilator support for people who need mechanical ventilation, in invasive and non-invasive applications, according to the FDA. The V+Pro version includes only the ventilation function, with external high- and low-pressure oxygen capability. The trade publication Respiratory Therapy also reported the recall on May 21, citing the FDA alert.

The FDA notice points to the agency's enforcement report and recall database for further details on the action.