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 the 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

Updates to this page

Published 26 July 2021