You should receive direct notification from the manufacturer or their representative for any field safety notice (FSN) affecting medical devices supplied to your centre.

If you receive an FSN from a manufacturer YOU MUST ALWAYS ACT ON IT. If you have a question about a particular FSN contact the manufacturer.

Copies are available here for information only, examples below - please note that list below is not exhaustive.

To download further information please click on the MHRA reference number.


BD: Covera and Covera Plus Vascular Covered Stent

Based on customer feedback, BD has identified that the impacted Covera™ and Covera™ Plus Vascular Covered Stents have the potential to exhibit deployment issues (i.e., failure to deploy the covered stent) due to slide block bond failures (failure of force transmitting joint) in the device handle.

10 January 2023

MHRA reference: 5017034


BD: Venovo Venous Stent System

Based on internal investigation, the lots from Table 1 were errantly distributed and may result in exposure to known issues of potential delayed deployment and silicone embolisation in the event the proximal end of the Venovo™ Venous Stent System does not immediately expand upon deployment and remains connected to the stent cushion on the delivery system.

10 January 2023

MHRA reference: 5044151


Vascutek: custom made fenestrated devices

Vascutek has identified proximal ring stent fractures in certain Anaconda (Custom made) devices.

11 November 2022

MHRA reference: 5005552


Medtronic Valiant Navion™ Thoracic Stent Graft System Recall

February 2021

Medtronic valiant Navion surveillance advice

Navion Letter to patients_Template

Urgent Field Safety Notice Medtronic Valiant Navion™ Thoracic Stent Graft System Recall


Cook Medical Ltd: Urgent Field Safety Notice: Inferior Vena Cava (IVC) Filter

15th September 2021

FSN & FCA reference: 2021FA0006


Medtronic Ltd: Urgent Field Safety Notice: Venous Self Expanding Stent System:

November 2021

Medtronic reference FA1197



GE Medical Systems: Innova IGS system

May 2021

GE Healthcare reference: 12504-2


Philips Health Systems: CT Fluoroscopy Digital Video Interface (DVI) Package with Ceiling Mounted Portegra2 Extension/Spring Arm by Mavig

April 2021

FSN reference: 72800751 Revision: A


Medical Device Alert MDA/2019/023

4th June 2019

After careful consideration and consultation, the MHRA has issued a Device Alert, published on 4th June 2019, relating to drug eluting technologies. Members are advised to take note of the content, and make arrangements as they see fit, in the light of the Alert. 

To view the alert please click HERE.