Dräger Medical, Covidien Recall More Than 2,700 Ventilators

Dräger Medical and Covidien separately are recalling a total of more than 2,700 ventilators.

The recall of more than 2,000 Evita V500 and Babylog VN500 ventilators manufactured and distributed from June 2011 to June 2015 are due to concerns about faulty batteries. Both ventilators provide breathing support for premature babies weighing at least 14 ounces. The Evita model also may be used in children and adults.

According to Dräger, the ventilator batteries don’t last as long as expected, and the indicator light shows sufficient charge even when the battery is depleted. If a ventilator were to shut down, a patient may not receive enough oxygen, leading to potential injury or death.

The company sent an urgent medical device recall letter on July 13 informing customers that it plans to replace faulty batteries.

Covidien’s recall, also Class 1 involves 657 Puritan Bennett 980 ventilators produced and distributed between March 2014 and June 2015. When set to neonatal volume control plus mode with active humidification, a software glitch may cause the amount of air being delivered to be lower than the programmed amount. The malfunction could result in injury or death.

Covidien sent an urgent field corrective action notice to customers saying it will implement a software update to correct the error.

Stay up to date on regulatory stories like this one by subscribing to The GMP Letter. For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation.