Covidien Recalls Puritan Bennett 980 Series Ventilator Due to Manufacturing Assembly Error

U.S. Food and Drug Administration sent this bulletin at 01/03/2022 01:01 PM EST

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FDA - Center for Devices and Radiological Health

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Covidien, LP Recalls Puritan Bennett 980 Series Ventilator Due to Manufacturing Assembly Error

Covidien, LP (part of Medtronic) is recalling its Puritan Bennett 980 (PB980) Series Ventilator due to a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop working as intended. If this occurs, this could result in the loss of ventilation and serious adverse events for the patients including death.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

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Questions?

Customers with questions about this recall should contact your Medtronic representative or Technical Service at 1-800-255-6774.