Device safety informationMHRA
Paclitaxel coated devices (PCD) used safety warning over a safety concern
Following a review, the MHRA has updated previous guidance (DSI/2022/003) on the use of paclitaxel coated devices (PCD) in the treatment of peripheral arterial disease (PAD).
What to do now
Users of Paclitaxel coated devices (PCD) used in the treatment of peripheral are asked to act on new safety information.
- Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
- Check the model, lot or serial number against the details on this page.
- Any incident involving the device can be reported through the 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
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.
Do not throw away a device you rely on until a replacement has been arranged.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2024/001). Quoted as issued.
Summary
Following a review, the MHRA has updated previous guidance (DSI/2022/003) on the use of paclitaxel coated devices (PCD) in the treatment of peripheral arterial disease (PAD).
The risk
Devices Details Device Name: Paclitaxel coated devices (PCD) used in the treatment of lower limb vascular stenosis / peripheral arterial disease (PAD) Affected lot numbers/serial numbers: All makes / models
Advice for healthcare professionals
Paclitaxel coated devices (PCD) can be considered (where indicated) as a clinical treatment option for patients experiencing peripheral arterial disease (PAD), including patients with critical limb ischemia (CLI) or intermittent claudication (IC)
Previous MHRA advice relating to the use of the lowest dose PCD available and to avoid/reduce repeated exposure of paclitaxel coated devices is withdrawn
Routine patient follow-up should continue as per standard of care
Direct any suspected adverse incidents associated with PCD to your national reporting system. 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:
details of the device, including manufacturer, model, and batch number
details of problems with the device and when the problems started
To assist with the capture of long-term, high quality follow-up outcomes data for possible future evaluation, please ensure details are completed utilising the National Vascular Registry (NVR) and also the Outcomes and Registries Programme (ORP) for follow-up outcomes in England.
NVR Data Entry System/VSQIP
Advice for patients
The advice in this notice is aimed at the healthcare professionals and teams who are responsible for providing and monitoring medical devices used to treat peripheral arterial disease
No new safety concerns have been identified for patients
If you or somebody in your care has received one of these devices and are concerned, please contact your GP, or your local vascular services / consultant for advice
Open the MHRA notice
Questions
Why has Paclitaxel coated devices (PCD) used in the treatment of peripheral been recalled?
Users of Paclitaxel coated devices (PCD) used in the treatment of peripheral 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?
Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.
Who replaces the device?
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.