The Recall Desk
SevereFDA (Devices)·Z-0347-2022·Announced 2021-12-15

Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Assembly Defect

Covidien LLC is recalling 278 units of the Puritan Bennett 980 Series Ventilator due to a manufacturing defect that may cause the device to become inoperable during clinical use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per regulatory standards. No illnesses or injuries have been reported in connection with this manufacturing defect, which prevents escalation to Critical status.

Plain-English summary

Covidien LLC is recalling the Puritan Bennett 980 Series Ventilator, model 980X1ENDIUU. The recall affects 278 units distributed worldwide, including throughout the United States.

A manufacturing assembly error resulted in incorrect assembly of a capacitor within the ventilator. This defect may cause the device to become inoperable during clinical use.

Affected units are identified by specific serial numbers that have been provided by the manufacturer to the FDA. Hospitals and medical facilities in possession of affected units should verify their equipment against the manufacturer's list of involved serial numbers.

The recalled product

Product
Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
Manufacturer
Covidien Llc
Category
Medical Device — Ventilator
Hazard
  • manufacturing-defect
  • device-inoperability

Distribution

Distributed nationwide across the United States.

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