Primary source: Consultez le courrier de la société Medtronic France SAS de juin 2025 (05/06/2025)
Translated From French
PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.
Medtronic has initiated a recall of specific serial numbers of the Newport HT70 and HT70 Plus ventilators and associated spare parts, recommending the cessation of clinical use of these devices.
The failure of these ventilators can result in serious health risks, including respiratory failure and potential fatalities, necessitating immediate action from healthcare providers to safeguard patient well-being.
Healthcare facilities using the affected Newport HT70 and HT70 Plus ventilators need to cease their use and evaluate the risk for their patients, following established protocols for device monitoring and replacement.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Healthcare facilities using the affected Newport HT70 and HT70 Plus ventilators need to cease their use and evaluate the risk for their patients, following established protocols for device monitoring and replacement.
Medtronic France SAS is recalling specific serial numbers of the Newport HT70 and HT70 Plus ventilators due to identified issues that could lead to serious incidents or fatalities. This recall stems from investigations into customer complaints revealing problems with circuit board capacitors that could lead to ventilator failure or failure to sound alarms in critical situations.
What changed: Medtronic has initiated a recall of specific serial numbers of the Newport HT70 and HT70 Plus ventilators and associated spare parts, recommending the cessation of clinical use of these devices.
Why it matters: The failure of these ventilators can result in serious health risks, including respiratory failure and potential fatalities, necessitating immediate action from healthcare providers to safeguard patient well-being.
Practical implication: Healthcare facilities using the affected Newport HT70 and HT70 Plus ventilators need to cease their use and evaluate the risk for their patients, following established protocols for device monitoring and replacement.
Published from the regulator source ingestion pipeline after PV impact triage.
All customers handling Infinion CX Leads must stop using these devices, segregate them, and return them to Boston Scientific as per the recall protocol communicated on June 17, 2026.
Facilities must ensure that appropriate alternative monitoring is established for patients before performing software updates and include the User Manual addendum with the equipment.
Users must carefully inspect the VentStar Resus Neo hoses for damages as per the product's Instructions for Use (IFU) and discard any hoses showing signs of cracks or detachments before use.
Immediate quarantine and destruction of all affected lots are mandated. Affected inventory must be checked, and customers must be notified if products have been resold or transferred.
