Covidien's ventilator recall gets hit with FDA's 'most serious' Class 1 label

Covidien's ($COV) recent ventilator recall has taken a more ominous turn. The FDA assigned its most-serious Class 1 status to the matter--a software snafu that can cause the product to shut down, leaving critically ill patients to breath on their own.

A Class 1 recall is bad news for companies, meaning that there's a risk of serious injury or death if someone uses the medical device in question.

Covidien launched a voluntary recall in December affecting its Puritan Bennett 840 Series Ventilator, and notified customers by letter, according to the FDA. At issue: a software problem that can potentially trigger a diagnostic code that would shut the ventilator down. That's a big concern, considering that critically ill patients placed on the device would then be left to breath on their own, something that may not be possible without the ventilator.

The FDA noted that the recall affects batches of the Puritan Bennett 840 made from April 30, 1998 through March 12, 2010 that were distributed from Aug. 1, 2008 through Oct. 31, 2010. Covidien recommended that customers keep using the ventilators until they can install the software update.

Class 1 recall aside, Covidien is proceeding with a number of steps intended to help restore healthier revenue growth since it spun out its drug business into Mallinckrodt ($MNK) in June. Those efforts have included job cuts and plant closures, but also acquisitions, such as Covidien's plan to buy PillCam maker Given Imaging ($GIVN) for $860 million. As well, the Dublin-based company has focused on beefing up its presence in emerging markets, and recently grabbed a manufacturer in Brazil and forged a joint venture in China.

- read the FDA's full Class 1 notice

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