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 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