The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2329-2015·Announced 2015-08-26

FDA Recalls 657 Puritan Bennett 980 Ventilators Due to Volume Defects

The FDA is recalling 657 Puritan Bennett 980 Ventilators because tidal volumes may be lower than set in neonatal mode, potentially causing respiratory compromise.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized."

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 657 units of the Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. The devices are manufactured by Covidien LP (formerly Nellcor Puritan Bennett Inc.) and are designed for use on neonatal through adult patient populations requiring respiratory support or mechanical ventilation.

The recall was initiated due to reports where tidal volumes reaching patients were lower than the set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.

The affected units were distributed worldwide, including the United States (nationwide), Canada, and numerous other countries. The specific model codes affected are 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, and 980N3ENDIUUS.

The recalled product

Product
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
Manufacturer
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Category
Medical Device — Ventilator
Hazard
Affected units
657

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 (8)

  • PB980 Ventilator (980xxxxxxxx): 980U1ENDIUU
  • 980U1ENDIUUS
  • 980U3ENDIUU
  • 980U3ENDIUUS
  • 980N1ENDIUU
  • 980N1ENDIUUS
  • 980N3ENDIUU
  • 980N3ENDIUUS

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Covidien LP (formerly Nellcor Puritan Bennett Inc.)

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