Field Safety Notices: 22 to 26 August 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 August 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

bioMérieux: VIDAS® 3 SOFTWARE V1.4

26 August 2022

IVDs, Immunology

MHRA reference: 2022/008/025/596/010

Boston Scientific: Promus ELITE™ Monorail™ Everolimus-Eluting Platinum Chromium Coronary Stent System - 3.0 x 20mm

04 April 2022

Implants, Non Active, Coronary Stents

MHRA reference: 2022/004/006/291/002

Cook Medical: Various

18 August 2022

Surgical Instruments, Minimal Access

MHRA reference: 2022/008/026/596/002

DE Healthcare: SYR CARTR S/ASP DUAL 2.2ML ECO

Ref 6365

Dental Syringes And Needles

MHRA reference: 2022/008/018/599/003

Med-Fit: Vagus Nerve Stimulator/Med-Fit/Everyway Medical

05 August 2022

External Nerve Stimulators

Model: VNS-001

MHRA reference: 2022/008/019/599/010

Med-Fit: CES Ear Clip

M202207

External Nerve Stimulators

Model: HME-01

MHRA reference: 2022/008/019/599/011

Medtronic: Cobalt XT, Cobalt, Crome Implantable Cardioverter/Defibrillator Systems

August 2022

Implants, Active, Defibrillators

Model: Cobalt XT VR: DVPA2D1, DVPA2D4

Cobalt XT DR: DDPA2D1, DDPA2D4

Cobalt XT HF: DTPA2D4, DTPA2D1

Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1

Cobalt VR: DVPB3D1, DVPB3D4

Cobalt DR: DDPB3D1, DDPB3D4

Cobalt HF: DTPB2D4, DTPB2D1

Cobalt HF Quad: DTPB2QQ, DTPB2Q1 Crome VR: DVPC3D1, DVPC3D4

Crome DR: DDPC3D1, DDPC3D4

Crome HF: DTPC2D4, DTPC2D1

Crome HF Quad: DTPC2QQ, DTPC2Q1

Cobalt XT HF Quad: DTPA2D1G, DTPA2QQG

MHRA reference: 2022/006/024/595/005

Medtronic: HeartWare® Ventricular Assist System (HVAD)

FA958 Phase II

Implantable Ventricular Assist Devices

Model: Controller (1401, 1403, 1407, 1420)

Battery (1650DE)

Controller AC Adapter (1425, 1430)

Controller DC Adapter (1440)

Alarm Adapter (1450)

Data Cable (1575)

MHRA reference: 2021/003/004/487/008

Mobidiag: Novodiag Bacterial GE+

17 August 2022

IVDs, Bacteriology

MHRA reference: 2022/008/019/596/001

Nobel Biocare: N1 TiUltra TCC NP 3.5x13mm

Ref PFA 2208

Implants, Dental

MHRA reference: 2022/007/028/701/087

Updates to this page

Published 31 August 2022