Field safety notices - 16 May - 20 May 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 16 - 20 May 2016


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

3M Deutschland: 3M ESPE Clinpro Glycine Prophy Powder with TCP

11 May 2016

Dental materials

MHRA reference: 2016/005/013/701/001

Cordis Corporation: Cordis PRECISE® PRO RX Nitinol Stent System

04 May 2016

Implants, non-active, carotid artery stents

MHRA reference: 2016/005/004/701/022

Corin: MetaFix Collarless Stem

2 May 2016

Joint prosthesis, hip

MHRA reference: 2016/005/005/601/005

Eastbourne Pharmaceuticals: Bone Wax (St Georges Hospital formula) Sterile 10G

07 March 2016

Implant materials, polymers

MHRA reference: 2016/003/009/291/002

Hoya Corporation: PENTAX Video Duodenoscope

FSCA-PMJ-16-01-1Endoscopes, Flexible

Model: ED-3490TK

MHRA reference: 2016/005/018/291/021

Immuno-Mycologics: Histoplasma Yeast CF Antigen Dilute

09 May 2016

IVDs, bacteriology

MHRA reference: 2016/005/018/071/002

Impac Medical Systems: Monaco RTP System


Radiotherapy planning and verification systems

MHRA reference: 2016/005/013/701/008

Innovision: Innocor

18 May 2016

Diagnostic measurement and monitoring

Model: INN00400

MHRA reference: 2016/005/017/291/026

Intuitive Surgical: 5 - 8 mm Cannula Seal 12 mm & Stapler Cannula

Intuitive Surgical - 2955842-05/09/16-006-C

Endoscopes, rigid

MHRA reference: 2016/005/010/701/005


09 May 2016.

Cardiac assist pumps

MHRA reference: 2016/005/016/291/012

Medos Medizintechnik: deltastream MDC , iLA activve & i-cor console

CAPA15-09 Heart lung machines

Model: MEMDC0001, 5000001 & 40000104

MHRA reference: 2016/005/018/291/005

Medtronic: Activa PC Neurostimulator, Activa SC Multi-program Neurostimulator, Activa PC+S, Activa RC Multi-Program Rechargable Neurostimulator, Soletra and Kinetra

May 2016

Implants, active, stimulators, neuro

Model: 37601, 37602, 37603, 37604, 37612, 7426 and 7428

MHRA reference: 2016/005/017/291/033

Medtronic: DBS Extension

May 2016

Implants, active, leads, neuro

Model: 7483, 37086, 37087

MHRA reference: 2016/005/017/291/034

Novus Scientific: TIGR Matrix Surgical Mesh

11 May 2016

Implants, non-active, abdominal & hernia mesh

Model: NSTM1015E, NSTM1520E, NSTM2030E

MHRA reference: 2016/005/017/291/011

Olerup SSP: Olerup SSP HLA typing kits

04 May 2016

IVDs, immunology

Model: A*01 Lots: 41V, 35X, 83Y A *24 Add-on Lot 32Y

MHRA reference: 2016/005/010/291/003

Redcord: Redcord Axis

14 April 2016

Therapy, traction

Model: Redcord Axis 18700/110030

MHRA reference: 2016/005/012/291/007

Siemens: Vista Enzyme 2 calibrator and Dimension Enz II cal 52903

12 May 2016

IVDs, clinical chemistry

MHRA reference: 2016/005/013/601/003

Siemens: N Latex Homocystein

May 2016

IVDs, clinical chemistry

MHRA reference: 2016/005/018/291/001

Siemens: Aptio Automation System/StreamLAB Analytical Workc

May 2016

IVDs, clinical chemistry

MHRA reference: 2016/005/019/601/008

TEOXANE: Teosyal; Teosyal PureSense


Implants, reconstructive, body contouring

Model: Ultimate

MHRA reference: 2016/005/013/291/018

VBM Medizintechnik: Laryngeal-Tube LTS-D Size 2 and 4

22 April 2016

Airway devices Model: LTSD

MHRA reference: 2016/005/013/291/001

Volcano Corporation: SW V 3.2.x, 3.3, 3.4 on S5/Core

06 May 2016

Ultrasound, imaging

Model: 435-0602. (01, 25.40)

MHRA reference: 2016/005/006/291/011

Zimmer: Anatomical Shoulder 2.0 Dome Centric

8 May 2016

Joint prosthesis, shoulder

MHRA reference: 2016/005/018/291/016

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