Device safety informationMHRA
No-React® cardiovascular bioprosthesis implantables safety warning over a safety concern
The MHRA emphasises the importance of national reporting of any suspected adverse incidents associated with the product following CE certification withdrawal and cease of manufacturing.
What to do now
Users of No-React® cardiovascular bioprosthesis implantables are asked to act on new safety information.
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2023/009). Quoted as issued.
Summary
The MHRA emphasises the importance of national reporting of any suspected adverse incidents associated with the product following CE certification withdrawal and cease of manufacturing.
The risk
Product details Device Name: All No-React® cardiovascular bioprosthesis implantables. Affected lot numbers/serial numbers: All.
Advice for healthcare professionals
Products already in use or on the UK market are considered safe.
Direct any suspected adverse incidents associated with BioIntegral Surgical No-React implants to your national reporting system. This is to ensure effective post-market surveillance is in place for both previously implanted devices and remaining unused devices on the UK market. Healthcare professionals should report incidents:
in England and Wales to the Yellow Card scheme or via the Yellow Card app
in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
in Northern Ireland to the Northern Ireland Adverse Incident Centre and their local incident recording system
When reporting suspected adverse incidents, please include the following information, if possible.
details of the device, including manufacturer, model, and batch number
details of problems with the device and when the problems started
The advice in this notice is aimed at the healthcare teams who are responsible for providing and monitoring implantable cardiovascular devices.
No new safety concern has been identified for patients.
If you or somebody in your care has received one of these devices and are concerned, please contact your hospital for advice.
Advice for patients
The advice in this notice is aimed at the healthcare teams who are responsible for providing and monitoring implantable cardiovascular devices.
No new safety concern has been identified for patients.
If you or somebody in your care has received one of these devices and are concerned, please contact your hospital for advice.
Open the MHRA notice
Questions
Why has No-React® cardiovascular bioprosthesis implantables been recalled?
Users of No-React® cardiovascular bioprosthesis implantables are asked to act on new safety information. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.