Covidien‘s (NYSE:COV) recall of its Puritan 980 ventilator just 8 months after its clearance for the U.S. market earned the FDA’s highest-level Class I status for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
A programming glitch in models of the ventilators using the 2.8 software version may stop working after the air and oxygen supplies are disconnected and then reconnected, the FDA said last week. The Oct. 1 recall covers Puritan 980 devices made between March 3 and August 19 and distributed up until August 22, according to the FDA.
"This can lead to serious health problems or death if the healthcare provider does not connect the patient to another ventilator or to a different form of breathing support," according to the recall notice.
Covidien last February said it won 510(k) clearance from the FDA for the Puritan 980, the latest in the Puritan Bennett line, as well as CE Mark approval in the European Union.
Covidien plans to have representatives update the software "as soon as possible," the FDA said, noting that Covidien notified customers Oct. 3. The ventilators are safe to use provided they’re connected to 2 separate gas sources in case 1 of them fails, according to the notice.
Covidien early this year issued a Class I recall for another of its Puritan Ventilators, the Puritan Bennett 840, also because of a software issue.
