Field Safety Notices: 19 to 23 July 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 19 to 23 July 2021.
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
EKF Diagnostics Holdings: Beta-hydroxybutyrate Liquicolor
12 July 2021
IVDs, clinical chemistry
Model: Beta-hydroxybutyrate Liquicolor
MHRA reference: 2021/007/020/291/007
Emergo Europe: BIB/Orbera/Orbera365 Intragastric Balloon Systems
01 July 2021
Implants, non active, gastrointestinal
Model: B-40800, B-50000, B-50012
MHRA reference: 2021/007/013/291/015
Getinge Cardiopulmonary: Tubing Set
23 July 2021
Infusion & transfusion, heart lung circuits
MHRA reference: 2021/007/023/291/002
GORE & Associates: Molding and Occlusion Balloon Catheter
July 2021
Vascular cannula and catheters
Model: MOB37
MHRA reference: 2021/007/009/701/095
Medtronic: Activa Clinician Programmer Application Phase 2 - software update
July 2021/FA968 & FA969
Implantable neuro stimulators
Model: A610
MHRA reference: 2021/003/017/487/002
Medtronic: Endurant II, IIs Stent Graft System Radiopaque Marker Detachment
June 2021/FA982
Implants, non active, endoprostheses for aortic aneurysms
Model: ETUF3214C102EE, ETBF3216C166EE, ESBF3614C103EE, ETCF3636C49EE
MHRA reference: 2021/007/016/291/016
Medtronic: HeartWare Ventricular Assist System – Phase II (HVAD)
July 2021/FA981 Phase II
Implantable ventricular assist devices
Model: 1104
MHRA reference: 2021/006/004/487/001
Medtronic: Pipeline Flex Embolization Device,
Pipeline Flex Embolization Device with Shield Technology
July 2021/FA985
Intracranial flow diverters / stents
MHRA reference: 2021/007/023/291/001
Olympus: SOLTIVE PREMIUM LASER & SOLTIVE PRO LASER
July 2021/QIL 154-006
Therapy, lasers
Model: Premium EGTFL-PLS & Pro EGTFL-SLS
MHRA reference: 2021/007/009/487/002
Olympus: GASTROINTESTINAL VIDEOSCOPE & COLONOVIDEOSCOPE
July 2021/QIL 154-007
Endoscopes, flexible
Model: GIF-EZ1500 & CF-EZ1500DL, CF-EZ1500DI & CV-1500 (²*EVIS X1 Video SYSTEM Center CV-1500)
MHRA reference: 2021/007/016/291/005
Smith & Nephew: Birmingham Hip Square Headed Nail
4 July 2021
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference: 2021/007/016/291/001
Teleflex Medical: Slick Set, Flexi-Set, RUSCHELIT Safety Clear Plus, RUSCHELIT Super Safety Clear, Super Safety Clear Flexiset, Endotracheal Tube with Cuff/Murphy, Endotracheal Tube Magill, Endo Tracheal Tube Murphy Eye
July 2021/EIF-000464_EIF-000479
Airway devices
Model: Various
MHRA reference: 2021/007/016/291/014