The CareFusion EnVe Ventilator recall has been deemed a Class I, the U.S. Food & Drug Administration (FDA) just announced. A Class I is the agency’s most serious designation and is defined as having a reasonable probability of serious adverse health consequences or death associated with use of the defective, recalled unit.
The Class I designation updates CareFusion’s previously announced recall of its EnVe ventilators.
In June, CareFusion initiated a voluntary recall for products manufactured between December 2010 and January 2012; this action has no effect on the manufacture or distribution of current products. The June urgent Recall Notification CareFusion sent to its customers stated that it had identified potential risks associated with the EnVe ventilator.
A leak may occur in the patient breathing circuit or the system, resulting in the ventilator not holding the set Positive End Expiratory Pressure (PEEP) value, either intermittently or continuously. The device will activate both audible and visual alarms to notify the health care professional that patient ventilation delivery may be compromised.
Remediation plans previously announced by the company are underway and will be completed at customers’ sites. To date, no reports of patient harm associated with the affected devices have been received
The CareFusion Customer Support Center can be reached, toll-free, at 1.800.554.8933. Adverse reactions related to the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program: By mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, Maryland, 20852-9787; by telephone at 1.800.332.1088; by fax at 1-800.FDA.0178; or online at www.fda.gov/medwatch.
This is not the first time that CareFusion devices were involved in a recall deemed a Class I by the FDA. We recently reported that the FDA deemed the CareFusion AirLife Infant Breathing Circuit a Class I recall.
Earlier this year, we wrote that CareFusion NicoletOne Software and Nicolet devices were named in a Class I recall. The recalled devices and associated software are used for functional brain mapping procedures by physicians and surgeons who treat patients diagnosed with seizure disorders and brain tumors. Recall issues may result in the surgeon resecting the wrong brain tissue or may cause the surgeon to fail to resect pathological tissue.
Prior to that we wrote that in three separate actions, CareFusion updated its AVEA® ventilator recall; that certain CareFusion EnVe Ventilators were recalled; and that CareFusion issued a recall for some of its Alaris PC Units electronic infusion devices. All three actions were deemed Class I recalls by the FDA.