The FDA placed Class I status on the recall, a label reserved for "the most serious type of recall" in which "there is a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the FDA notice.
Covidien last month recalled a series of Power Pac batteries distributed by its Newport Medical subsidiary. The company warned of possible issues with batteries that are shipped with Newport HT70 and HT70 Plus ventilators in response to reports that some batteries were resorting to back-up power sooner than expected.
In some instances the ventilator may erroneously indicate that the Power Pac is fully charged, and in other instances the ventilator may resort to a backup battery as soon as its unplugged from AC power, the company said.
The device maker is asking users to check for affected batteries and contact the company to request a no-charge replacement. In the mean time, customers using the ventilators should ensure that an alternative source of power is available, according to the FDA report.
Covidien acquired Newport Medical Instruments last year for $108 million, part of the company’s strategy to broaden its respiratory solutions and ventilation portfolio.
COV shares were up 0.6% to $64.61 as of about 11:55 a.m. today.