FDA slaps Class I on Covidien's ventilator battery recall

Covidien is recalling batteries used in its Newport HT70 ventilators.--Courtesy of Covidien

Last month, Covidien ($COV) launched a recall of battery packs used with its Newport HT70 ventilators, and now the FDA has assigned its most serious designation to the problem, warning that the malfunctioning batteries could lead to injury or death.

Covidien said certain lots of its Power Pac batteries may fail to charge or prematurely revert to emergency backup power, which only lasts about 30 minutes. The problem could lead to serious risks to patients if they aren't near another power source, and Covidien is asking affected customers to send their batteries back in for free replacements, in the meantime using Newport ventilators only when auxiliary power is available.

The FDA reserves its Class I tag for recalls that carry the risk of serious injury or death, and the agency is asking patients and physicians to report any problems through its online MedWatch system.

Looking through the FDA's MAUDE database of device reports, customers reported hissing noises, burning smells and required manual ventilation due to the battery failure, but there have so far been no serious adverse event reports.

The Power Pac recall is Covidien's latest spot of trouble with ventilator batteries, coming on the heels of two warnings issued in the U.K. last year over Legendair and Supportair. Those devices were plagued by internal battery failure Covidien blamed on a faulty circuit board.

- read the FDA notice

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