FDA

One Death, Six Complaints: Covidien Recalls Puritan Ventilators Due to Manufacturing Error

By MedTech Intelligence Staff
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FDA

A capacitor manufacturing assembly error could cause the device to become inoperable.

Covidien, LP (part of Medtronic) is recalling its Puritan Bennett 980 Series Ventilator as a result of a manufacturing assembly error that could either render the device inoperable or it could stop working as intended. The ventilators were distributed between February 23, 2017 and April 4, 2020.

The capacitor manufacturing assembly error could lead to a loss of ventilation or hypercarbia, hypoxemia, neurological injury or death. Although the Class I recall only affects 135 devices in the United States, six complaints have been filed and one death has been reported in connection with the device issue.

Healthcare providers and device users have been instructed to discontinue the use of these ventilators.

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