The Recall Desk
CriticalFDA (Devices)·Z-0344-2022·Announced 2021-12-15

Puritan Bennett 980 Series Ventilators Recalled for Incorrect Capacitor Assembly

Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to incorrect capacitor assembly that may cause devices to become inoperable during patient use.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is classified as FDA Class I, which is a critical hazard designation. A ventilator that becomes inoperable during patient use presents an imminent danger to patient life.

Plain-English summary

Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators (model 980U3ESDIUU) that were distributed worldwide, including throughout the United States. These mechanical ventilators are used in healthcare settings to assist patients with breathing.

The recall is being issued due to a manufacturing defect in which capacitors within the ventilators were assembled incorrectly during production. This assembly error may cause affected ventilators to become inoperable during use.

Affected units can be identified using the following serial numbers: 35B1700548, 35B1700551, 35B1700560, 35B1700572, 35B1700577, 35B1700603, 35B1700606, and 35B1700615. Healthcare facilities and medical equipment users who possess these ventilators should contact Covidien immediately for instructions on replacement or repair.

The recalled product

Product
Puritan Bennett 980 Series Ventilator, 980U3ESDIUU
Manufacturer
Covidien Llc
Category
Medical Device — Respiratory
Hazard
  • device-inoperability
  • manufacturing-defect

Distribution

Distributed nationwide across the United States.

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