Field Safety Notice: 29 April to 3 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 29 April to 3 May 2019.


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

Boston Scientific: Xenform - Uphold - Polyform - Pinnacle

29 April 2019

Implants, non active, implantable incontinence and prolapse devices

Model: Xenform™ Tissue Repair

MHRA reference: 2019/004/029/291/001

Cook Medical: Zenith Alpha Abdominal Endovascular Graft

25 April 2019

Implants, non-active, endoprostheses for aortic aneurysms

MHRA reference: 2019/004/026/487/001

Cook Medical

17 April 2019

Implants, non-active, non-vascular stents

MHRA reference: 2019/005/001/701/036

DiaMed (Bio Rad): IH-QC1

29 April 2019

IVDs, clinical chemistry

MHRA reference: 2019/006/001/487/010

EBR System: WiSE CRT Electrode and Delivery Catheter

26 April 2019

Implants, active, intracardiac (leadless)

MHRA reference: 2019/005/001/701/011

Edwards Lifesciences: All lots manufactured between December 13, 2017 and January 18, 2019 and shipped between the dates of December 2017 and February 2019. Commercial name/brand name/make: - 830705F - Catheter, Fogarty® Dilation Atrioseptostomy Catheter 5FR 50 cm ster. F/nat. rub. Latex. - 830515F - Catheter, Miller Balloon 5FR 50 cm Atrioseptostomy W/nat. rub. LatexFogarty® Dilation Atrioseptostomy Catheter.

FCA 131

Vascular cannula and catheters

Model: 830705F / 830515F

MHRA reference: 2019/004/024/701/023

GE Healthcare: Achilles EXP II

FMI 14018

Ultrasound, imaging

MHRA reference: 2019/004/030/487/015

Gambro (Baxter): FA-2019-019

01 May 2019

Dialysis, haemofilters

Model: Prismaflex

MHRA reference: 2019/004/030/487/013

Millipore: Bioscot Anti-C Blood Grouping Reagent (MS-273)

April 2019

IVDs, blood transfusion

Model: TW-5ML-B

MHRA reference: 2019/004/011/601/004

ORGENTEC Diagnostika: ENAcombi (aRG 514)

18 March 2019

IVDs, immunology

MHRA reference: 2019/005/001/291/005

Philips: EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50 and Affiniti 70

26 April 2019

Ultrasound, imaging

MHRA reference: 2019/005/001/291/008

Philips: Efficia 3/5 ECG Trunk Cable, AAMI/IEC

March 2019


MHRA reference: 2019/005/002/487/013

Siemens: Artis zee and Artis Q/Q.zen

5 April 2019

X ray, fluoroscopy systems

Model: Artis zee and Artis Q/Q.zen systems delivered since May 2018

MHRA reference: 2019/004/030/601/004

Surgimax: AEROtube®

28 March 2019

Airway devices

Model: AEROtube® - LK02-GB-M, Fiber Optics Laryngoscope Handles ECO (LED)

MHRA reference: 2019/003/029/601/002

Zimmer: Alvarado™ Knee Holder

30 April 2019

Orthopaedic surgical instruments - holding tools

MHRA reference: 2019/004/030/487/018

Published 7 May 2019