Medtronic Recalls Newport HT70 Ventilators Due to Spontaneous Shutdown Risk
Medtronic is voluntarily recalling Newport HT70 and HT70 Plus ventilators because they may shut down spontaneously without an alarm during normal operation.
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: "Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm."
Plain-English summary
Medtronic is issuing a voluntary field corrective action for all Newport HT70 and Newport HT70 Plus ventilators. The recall is being conducted because these devices may shut down spontaneously during normal operation without providing an accompanying alarm.
The affected devices are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for individuals requiring mechanical ventilation. The Newport HT70 family is applicable for infant, pediatric, and adult patients weighing 5 kg (11 lbs) or more. These ventilators are used in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
The recall covers 12,966 units distributed worldwide, including the United States and numerous international locations. Users of these devices should contact Medtronic or their healthcare provider for instructions on how to proceed with the corrective action.
The recalled product
- Product
- Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation…
- Manufacturer
- Newport Medical Instruments Inc
- Category
- Medical Device — Ventilator
- Affected units
- 12,966
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)
- All Newport Medical HT70 and HT70- Plus Ventilators
Distribution
Distributed nationwide across the United States.
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