Field Safety Notices: 15 to 19 March 2021

List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 March 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

Abbott: Assurity, Endurity

15 March 2021

Implants, active, pacemakers

Model: PM1152, PM1160, PM1172, PM1240, PM1272, PM2152,

PM2160, PM2172, PM2240, PM2260, PM2272

MHRA reference: 2021/003/016/487/016

Biosense Webster: CARTO Vizigo Bi-Directional Guiding Sheath

February 2021

Vascular cannula and catheters

MHRA reference: 2021/003/016/487/020

Boston Scientific: MAMBA 135 and MAMBA Flex 135 Microcatheters

March 2021

Vascular cannula and catheters

MHRA reference: 2021/003/016/487/021

GAMA Healthcare: Clinell Universal Wipes

22 January 2021

Disinfectants for medical devices

MHRA reference: 2021/003/012/601/013

GE Healthcare: MAC 2000

16 March 2021

Electrophysiology measurement

MHRA reference: 2020/012/014/401/010

B.Braun: HISTOACRYL Transparent / LAPFIX / PROSET OFX

15 March 2021

Adhesive control devices

Model: 1050060, 1050071

MHRA reference:2021/003/009/601/001

This Field Safety Notice (FSN) is an update to FSN dated 8 March 2021 and has subsequently been updated on 27 April 2021. These FSNs include different models and batch numbers.

Please note the FSN dated 15 March originally contained a typographical error referring to an FSN of 3 March. This has been amended by the manufacturer and now correctly refers to the FSN dated 8th March.

ICU Medical: Spiros

12 March 2021

Infusion & transfusion, administration sets

Model: 011-CH3967; CH3235

MHRA reference: 2021/003/012/701/025

James Leckey Design: MyWay

01 March 2021

Walking aids, rollators

Model: 173-1600, 173-2600, 173-3600

MHRA reference: 2021/003/015/601/004

Leica Biosystems: BOND Detection (various), BOND Instruments

11 March 2021

IVDs, cytopathology & histopathology

Model: DS9800, DS9390, TA9145, BOND-III, BOND-MAX.

MHRA reference: 2021/003/012/601/009

Medtronic: Signia Small Diameter Curved Tip Intelligent Reload

March 2021/FA965

Staples and staple guns

Model: SIGSDS30CTV, SIGSDS30CTVT, SIGSDL45CTVT

MHRA reference: 2021/003/012/487/007

Medtronic: MiniMed 780G Insulin Pump; MiniMed 670G Insulin Pump (only models used in Clinical Studies*)

March 2021/FA963

Infusion systems

Model: ump 780G models: MMT-1885, MMT-1886;

Kit 780G models: MMT-1895; MMT-1896;

Pump models Clinical Studies:

MMT-1740; MMT-1741; MMT-1742

MHRA reference: 2021/003/016/291/001

Medtronic: Activa Clinician Programmer Application

March 2021/FA968

Implantable neuro stimulators

Model: A610

MHRA reference: 2021/003/017/487/001

Medtronic: Activa Clinician Programmer Application

March 2021/FA969

Implantable neuro stimulators

Model: A610

MHRA reference: 2021/003/017/487/002

Nissha Medical Technologies: Vermed

15 March 2021

Endoscopes, flexible

MHRA reference: 2021/003/016/487/022

Siemens Healthcare: ADVIA Chemistry System

March 2021/CHI21-01.A.OUS

IVDs, clinical chemistry

MHRA reference: 2021/003/015/601/001

Siemens Healthcare: ADVIA 2120/2120i Hematology System

March 2021/ HSW21-01.A.OUS

IVDs, haematology

Model: See FSN

MHRA reference: 2021/003/015/601/003

Stryker: Pediatric Restraint System (Removable)-XPS Mattres

March 2021

Mattresses - active/passive and overlays

MHRA reference: 2021/003/005/291/009

Updates to this page

Published 22 March 2021