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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (ventilator) with a defect that poses a risk of harm (spontaneous shutdown without alarm), but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
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 thr
- 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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