Field Safety Notices: 4 to 8 May 2026
List of Field Safety Notices from 4 to 8 May 2026.
Overview
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
MHRA publishes the following for information only.
If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abbott Medical : Infinity and Proclaim
April 2026
GMDN codes: 37307, 64970
Model: 6660, 6661, 6662, 6663, 3660, 3661, 3662, 3363, 3664, 3665, 3667
MHRA reference: 39442964 2026/004/023/601/064
Abiomed, Inc: Impella Purge Cassette
31 March 2026
Infusion Pump Cassette
Model: 0043-0001;0043-0009
MHRA reference: 39420703 2026/004/002/601/034
Bayer Medical Care Inc. : MEDRAD Avanta Multi-Patient Disposable Set
1 May 2026
MHRA reference: 39438717 2026/005/006/601/082
MHRA reference: 39438717 2026/005/006/601/082 – Customer reply form
Boston Scientific Neuromodulation Corporation: TCN and CSK Reusable RF Electrodes
5 May 2026
MHRA reference: 39331784 2026/004/029/601/083
ELLA-CS: SX-ELLA Stent Danis (Danis stent)
30 April 2026
Polymer-metal oesophageal stent
MHRA reference: 39392653 2026/004/029/601/071
GE Medical Systems Information Technologies, Inc : ApexPro CARESCAPE Telemetry Server
FMI 36169
MHRA reference: 39439984 2026/005/005/601/057
Hamilton Medical AG: IntelliCuff
4 May 2026
MHRA reference: 39440437 2026/005/005/601/046
Intuitive Surgical, Inc: Da Vinci 5 Tower - Model: T5000
ISIFA2026-03-C
Model: 380746
MHRA reference: 39427051 2026/005/005/601/135
Medtronic, Inc : Pocket Adaptor Kit for Deep Brain Stimulation
May 2026
Model: Model 64001 and 64002
MHRA reference: 39442821 2026/004/016/601/072
PFM Medical Mepro GmbH: Multi-Snare
FSN-2026-01
Description : Intravascular extraction catheter-snare
MHRA reference: 39331189 2026/004/029/601/080
Philips Medical Systems Nederland BV : Philips Allura and Azurion systems
30 April 2026
Stationary angiographic x-ray system, digital
Model: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722400
MHRA reference: 39395062 2026/004/030/601/087
Pie Medical Imaging B.V. : 3mensio Workstation
April 2026
Radiology DICOM image processing application softw
Model: 10.7, including service packs 1-5 (SP1-5)
MHRA reference: 39441813 2026/005/006/601/144
MHRA reference: 39441813 2026/005/006/601/144 – User letter
The Binding Site Group Limited : EXENT® Elution Buffer 1
30 April 2026
MHRA reference: 39441213 2026/004/024/601/016
Updates to this page
-
First published.
-
First published.