Medtronic has announced a voluntary recall of select Newport HT70 and Newport HT70 Plus ventilators and certain related service parts for the devices.
The medtech giant issued a recall notification to customers last month, and it has now been classified as a Class I recall by the US Food and Drug Administration (FDA).
According to the FDA , there have been 63 medical device reports (MDRs) associated with the outlined issues, including two serious injuries and one death. There are 4,842 devices in commerce, according to the FDA鈥檚 recall database.
Medtronic advised discontinuing the clinical use of the affected device versions following an investigation into customer complaints relating to the devices shutting down during use and/or the devices鈥� shutdown alarms failing to sound effectively. The company said it had identified two separate capacitors on one of the ventilator鈥檚 controller printed circuit board assembly (PCBA) as the cause of the issues.
The agency noted that if a ventilator fails and does not provide adequate ventilation, the patient may not be able to breathe on their own, leading to low oxygen levels, high carbon dioxide levels, and potentially severe consequences like brain injury or death.
Also within the FDA鈥檚 recall notice, Medtronic added that the affected devices must be removed from circulation and that it will not be correcting the highlighted issues on affected ventilators or service parts and will no longer service the affected ventilators. The recall tag comes just over a year after Medtronic announced it would exit the ventilator market, citing unprofitability.
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By GlobalDataA recent study published in the聽 found that almost a third of adverse events (AEs) were reported late 鈥� notably, outside of the mandated 30-day reporting window 鈥� to the FDA鈥檚 centralised Manufacturer and User Facility Device Experience (MAUDE) database聽between September 2019 and December 2022.
As part of its internal processes for notifying the public on high-risk medical device recalls, the FDA鈥檚 Center for Devices and Radiological Health (CDRH) initiated a pilot last year that focused on improving the timeliness of communications around corrective actions being taken by companies with devices believed to be high-risk recalls.
