The Recall Desk
SevereFDA (Devices)·Z-0346-2022·Announced 2021-12-15

Puritan Bennett 980 Series Ventilator Recalled for Capacitor Assembly Defect

Covidien is recalling 278 Puritan Bennett 980 Series Ventilators (Model 980X1ENDIPC) due to incorrect capacitor assembly that may cause the device to malfunction during 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. The incorrect capacitor assembly may render the ventilator inoperable during use, creating a significant risk for patients dependent on mechanical ventilation.

Plain-English summary

Covidien Llc is recalling the Puritan Bennett 980 Series Ventilator, Model 980X1ENDIPC, due to a manufacturing assembly error. A capacitor within the device was assembled incorrectly, which may cause the ventilator to become inoperable during use.

The recall affects 278 units with GTIN/UDI 10884521172302 and serial numbers 35B1700447 and 35B1700405. The devices have been distributed worldwide and throughout the United States.

Patients and healthcare providers should immediately discontinue use of affected ventilators and contact the manufacturer or the FDA for further guidance. Healthcare facilities should verify their device serial numbers against the recall information to determine if they have affected units in their inventory.

The recalled product

Product
Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
Manufacturer
Covidien Llc
Category
Medical Device — Respiratory Equipment
Hazard
  • device-failure
  • assembly-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • GTIN/UDI - 10884521172302 Serial Numbers: 35B1700447 35B1700405

Distribution

Distributed nationwide across the United States.

Related recalls

Same category