The Recall Desk
SevereFDA (Devices)·Z-0343-2022·Announced 2021-12-15

Puritan Bennett 980 Ventilator Recalled for Capacitor Assembly Error

Covidien is recalling the Puritan Bennett 980 Series Ventilator due to incorrect capacitor assembly that may cause the device to become inoperable during patient 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 designation requires minimum severity score of 4. The device has a documented manufacturing defect that may render it inoperable during use. No reported deaths, injuries, or illnesses are documented in the source text.

Plain-English summary

Covidien Llc is recalling the Puritan Bennett 980 Series Ventilator (model 980U1ESDIUC) due to a manufacturing assembly error. The recall affects approximately 278 units distributed worldwide with US nationwide presence, identified by serial numbers 35B1700408, 35B1700412, 35B1700499, and 35B1700525.

The defect involves incorrect assembly of a capacitor within the ventilator. This error may cause the device to become inoperable during use.

Users of affected devices should stop using the ventilator immediately and contact Covidien Llc for instructions on device replacement or repair.

The recalled product

Product
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
Manufacturer
Covidien Llc
Category
Medical Device — Respiratory Equipment
Hazard
  • device-inoperability
  • assembly-defect

Distribution

Distributed nationwide across the United States.

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