Field Safety Notices: 14 to 18 January 2019

List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 January 2019

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

Abbott: HeartMate 3™ Left Ventricular Assist System

07 January 2019

Implantable ventricular assist devices

Model: 106524INT HM3 LVAS Kit

MHRA reference: 2018/004/009/291/032

Balt Extrusion: ECLlPSE2l

21 December 2018

Vascular cannula and catheters

MHRA reference: 2019/001/007/291/001

Convatec (Medtronic)

December 2018

Infusion & transfusion, administration sets

Model: Medtronic MiniMed Mio™ Advance Infusion Sets - MiniMed™ Mio™ Advance (MMT-242, MMT-242T, MMT-242600, MMT-247, MMT-247T, MMT-247600)

MHRA reference: 2018/012/020/487/003

Cook Medical: Entuit Secure Gastrointestinal Suture Anchor Set

13 December 2018

Sutures Model: Entuit

MHRA reference: 2019/001/007/701/013

Covidien (Medtronic): Parietex™ Composite Parastomal Mesh

December 2018

Surgical mesh for hernia repair.

MHRA reference: 2018/010/015/291/018

Innovative Design Orthopaedics: Long Glenoid Base Plate

01 September 2018

Joint prosthesis, shoulder

Model: 125476

MHRA reference: 2018/012/023/601/001

Innovative Design Orthopaedics: Verso Shoulder Humeral Shells and Verso Shoulder Stemmed Humeral

08 January 2019

Joint prosthesis, shoulder 124567; 124566; 124565; 124564; 124563; 124562; 124561; 124560

MHRA reference: 2019/001/007/601/002

Philips: Philips PageWriter TC Cardiographs (TC20/30/50/70)

19 December 2018

ECG

Model: The affected products are all PageWriter TC Cardiographs (TC20/30/50/70) manufactured before November 20, 2018 that are capable of operating under battery power and have lithium-ion batteries presently installed.

MHRA reference: 2019/001/015/487/001

Teleflex: Percuvance 29cm Shaft, Percuvance 36cm Shaft

14 January 2019

Surgical instruments, minimal access

MHRA reference: 2019/001/015/291/009

Updates to this page

Published 21 January 2019