The Recall Desk
SevereFDA (Devices)·Z-0352-2022·Announced 2021-12-15

Puritan Bennett 980 Series Ventilator Recall - Capacitor Assembly Error

Covidien is recalling 278 Puritan Bennett 980 Series ventilators (model 980X3ENDIUU) due to a capacitor assembly error 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 classification designates this manufacturing defect in a critical life-support device. No illnesses or injuries have been reported, but the potential for serious patient harm from ventilator failure during use warrants this severity level.

Plain-English summary

Covidien is recalling 278 Puritan Bennett 980 Series ventilators (model 980X3ENDIUU) distributed worldwide and throughout the United States.

A capacitor within affected units was incorrectly assembled during manufacturing. This error may cause the device to become inoperable during use, potentially leaving patients without necessary respiratory support.

Affected units can be identified by serial numbers from 35B1700308 through 35B1703383. Patients and healthcare facilities should immediately stop using any ventilators matching these serial numbers. Contact Covidien for instructions on obtaining a corrected device or replacement.

The recalled product

Product
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
Manufacturer
Covidien Llc
Category
Medical Device — Ventilator
Hazard
  • manufacturing-defect
  • device-failure

Distribution

Distributed nationwide across the United States.

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