| TGA Action ID |
RC-2025-RN-00483-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Newport HT70 and Newport HT70 Plus Ventilators
Model Number: HT70PM-WW-NA
GTIN: 10884521542266
Serial Numbers: N11HT701112706, N11HT701112702, N16HT720319437, N16HT720319438, N16HT720319439, N16HT720319440
ARTG 142414 (cancelled 30/10/2024) |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
ARTG: 142414 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Investigation into customer complaints have identified two separate capacitors on one of the ventilator’s Printed Circuit Board Assembly (PCBA), that, in case of failure, may result in one of two distinct outcomes: The ventilator either shuts down during use, thus necessitating the use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down.
No instances of both capacitors failing on the same PCBA board have occurred, nor are they anticipated to occur, because the cause for each outcome is distinct and does not overlap.
Medtronic has received 63 complaints and adverse health events associated with these problems, including two serious injuries and one death. |
| Instructions for Customers/Users |
The customer must remove all devices within their possession from service and replace with an alternate means of ventilation.
Healthcare providers with patients currently using the ventilators should assess the overall risk and appropriate timing for replacement of the devices.
After completing the transition to alternate ventilator(s), the customer should quarantine all devices and service parts and follow their facility’s processes for removal and disposal.
Medtronic will provide reimbursements to the affected customers.
This action has been closed out on 03/07/2026 |
| Action Commencement Date |
28/05/2025 |
| Responsible Entity |
|
| Contact Information |
rs.anzrecalls@medtronic.com - Medtronic Australasia |