Dive Brief:
- Medtronic has recalled ventilators and asked customers to stop using the devices because of a fault linked to two serious injuries and one death, the company said Wednesday.
- Affected Newport HT70 and HT70 Plus ventilators can shut down during use or fail to effectively sound the shutdown alert alarm. The company also recalled certain related Newport service parts. There have been 63 medical device reports about the problem.
- The Food and Drug Administration said in a Class 1 recall database entry about the fault this week that 4,842 affected ventilators are in commerce worldwide.
Dive Insight:
Medtronic committed to exiting its ventilator business last year but has continued to support customers and honor contracts as it winds down operations. Customer complaints led the company to investigate its HT70 and HT70 Plus devices, which provide mechanical ventilation to infants, children and adults in healthcare and home settings.
The investigation identified two separate capacitors on circuit boards in its ventilators as the cause of the problems. When the capacitors fail, the ventilators can shut down or fail to trigger a shutdown alarm. Medtronic said it does not expect both capacitors to fail at the same time.
The company wrote to customers and patients last month to explain the problem. Medtronic advised customers to stop using the affected devices. The faults could result in respiratory failure, inadequate gas exchange in the lungs, low oxygen saturation, hypoxia or delayed treatment, Medtronic said, leading to outcomes including brain injury or death. Infants and children may be at higher risk.
Medtronic told healthcare providers to adhere to the warnings in the ventilators’ manuals while deciding on alternate means of ventilation. The guidelines include ensuring that ventilated patients have the constant attention of trained caregivers and that an alternate power source and means of ventilation are available.
Medtronic will not update the devices to address the cause of the faults. The company will stop servicing ventilators affected by the recall.
The FDA shared Medtronic’s press release about the recall on its website.
