Field Safety Notices: 31 January to 4 February 2022

List of field safety notices (FSNs) from medical device manufacturers from 31 January to 4 February 2022.

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.

Acandis: DERIVO 2 Embolisation Device

20 January 2022

Intracranial flow diverters / stents

MHRA reference: 2022/001/025/601/500

Bolder Surgical: CoolSeal Generator

28 January 2022

Surgical, diathermy

MHRA reference: 2022/001/031/601/504

Invacare: Küschall Compact & Champion

24 January 2022

Wheelchairs, manual

MHRA reference: 2022/001/024/701/007

Medtronic: MiniMed 640G Insulin Pump (35983); 670G Insulin Pump (35983); 720G Insulin Pump (64889), 740G Insulin Pump (64890); 770G Insulin Pump (64891); 780G Insulin Pump (64891)

January 2022

Infusion systems

Pump models: MMT-1711, MMT-1712; MMT-1781, MMT-1782; MMT-1809, MMT-1810; MMT-1811, MMT-1812; MMT-1881, MMT-1882; MMT-1885, MMT-1886.

Kit models: MMT-1751, MMT-1752; MMT-1761, MMT-1762; MMT-1859, MMT-1860; MMT-1861, MMT-1862; MMT-1891, MMT-1892; MMT-1895, MMT-1896.

MHRA reference: 2022/002/001/291/007

Medtronic: Reveal LINQ with TruRhythm Insertable Cardiac Monitoring Systems

November 2021/FA978 Phase II

Implants, active, monitors and recorders

Model: LNQ11

MHRA reference: 2021/006/003/487/021

MMD: Oracol+

September 2018

IVDs, specimen receptacles

Model: S14

MHRA reference: 2022/001/027/601/001

Ossur: RESOLVE HALO

January 2022

Osteosynthesis, external fixators

Model: 505300T, 505400T, 505500T, 540C, 540D, 540V2, 515300T, 515400T, 515500T, 553CB, 554CB , 555CB , 510300CH, 510400CH, 510500CH, 515300C, 515400C, 515500C, 510400DH, 510500DH, 505300D, 505400D, 505500D, 515300D, 515400D , 515500D, 505300V2, 505400V2, 505500V2 , 515300V2 ,515400V2, 515500V2

MHRA reference: 2022/001/031/601/001

Stryker

January 2022

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference: 2022/001/027/487/003

Trinity Biotech: Menarini Premier Hb9210 Diluent Reagent

21 December 2021

IVDs, haematology

MHRA reference: 2022/002/001/291/006

Zimmer Biomet: Comprehensive Shoulder System & Arcos

27 January 2022

Joint prosthesis, shoulder

MHRA reference: 2022/002/001/291/009

Updates to this page

Published 8 February 2022