Field Safety Notices: 15 to 19 September 2025
Source: gov.uk (2025-09-23)

List of Field Safety Notices from 15 to 19 September 2025.

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 (https://mhra-gov.filecamp.com/s/o/ZgzvItYubBfGsOvg)

View a list of FSNs published since January 2020 (https://mhra-gov.filecamp.com/s/9g5cLjjFatXruS5U/d)

View FSNs since November 2014 (https://mhra-gov.filecamp.com/s/ZOxdOzRzP22RziUW/fo). FSNs before this date are on the National Archives website (https://webarchive.nationalarchives.gov.uk/*/http:/www.mhra.gov.uk/index.htm)

Abbott: TactiFlex™ Ablation Catheter, Sensor Enabled™

12 September 2025

Cardiac radio-frequency ablation system catheter

Model: Refer to FSN

MHRA reference: 36769415 (https://mhra-gov.filecamp.com/s/d/K9XmUmct5qXUxps7) 2025/009/012/601/033

Baxter Healthcare SA: Sharesource Claria

11 September 2025

FA Number: FAV-2025-007

Nephrology information system software

Product code: 5CGM01

Serial number: software versions 8.13.4

MHRA reference: 36757946 (https://mhra-gov.filecamp.com/s/d/7kSwGBMkBUz2jGL4) 2025/009/009/601/021

Beckman Coulter: DxC 500i Clinical Analyzer

06 August 2025

Model: Refer to FSN

MHRA reference: 36833955 (https://mhra-gov.filecamp.com/s/d/QVDjdBw0jgDfCltM) 2025/008/004/601/040 FSN

MHRA reference: 36833955 (https://mhra-gov.filecamp.com/s/d/HGSDNC4c8HLCmIGR) Vigilance response form

Datascope Corp/Getinge: Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP)

August 2025

Circulatory assist system, intra-aortic balloon

Model: Refer to FSN

MHRA reference: 36831024 (https://mhra-gov.filecamp.com/s/d/iknzYiYbHHj1wYh2) 2025/009/017/601/117

Diagnostic Grifols S.A.: Erytra

10 September 2025

Blood group/antibody screening analyser IVD automa

Product code: 210400 and 210401

Software versions: 4.5.0 and 4.6.0.

MHRA reference: 36770488 (https://mhra-gov.filecamp.com/s/d/VRODdGMPlUyTe5zl) 2025/009/012/601/078

DiaMed GmbH: ID-Anti-S, Test Serum ID-Anti-M, N, S, s, Fya, Fyb

18 August 2025

Bio-Rad Reference: FSCA-004-25

Anti-S [MNS3] red blood cell grouping IVD

Model: Refer to FSN

MHRA reference: 36834578 (https://mhra-gov.filecamp.com/s/d/J0VqPNxn9X06ciKX) 2025/008/xx-xxxx-xxxx

Epocal Inc/Siemens.: epoc BGEM BUN Test Card [25pk]

July 2025

epoc® Blood Analysis System

Model: Refer to FSN

MHRA reference: 36833855 (https://mhra-gov.filecamp.com/s/d/Jziowi5A32HkBcDx) 2025/007/002/601/091

ICU Medical Inc: HOTLINE HL-90 Blood & Fluid Warmer

18 September 2025

Convection blood/fluid warmer

Model: HL-90-UK-230

MHRA reference: 36809273 (https://mhra-gov.filecamp.com/s/d/BYUyd2fr8rtgy6yT) 2025/009/015/601/013

Inogen, Inc.: Inogen Rove 4™ Portable Oxygen Concentrator

September 2025

Ref: FSN-2025-002

Model: Refer to FSN

MHRA reference: 36775210 (https://mhra-gov.filecamp.com/s/d/R02E4HA8DONtM2NU) 2025/009/012/601/094

JRI Orthopaedics Ltd: VAIOS Humeral Stem H-AC 10mm Diameter

09 September 2025

Reference: NC592

Coated shoulder humeral stem prosthesis

Model: Refer to FSN

MHRA reference: 36773763 (https://mhra-gov.filecamp.com/s/d/kzg5ds7S2rRS3Tq3) 2025/009/001/601/040

Maquet Cardiovascular/Getinge: Heartstring III Proximal Seal System

August 2025

Reference Number: 1336551

Model: Refer to FSN

MHRA reference: 36774157 (https://mhra-gov.filecamp.com/s/d/U6yfUIHlDl1kyAol) 2025/008/019/601/041

Merit Medical Systems: PhD Hemostasis Valve™

29 July 2025

FSCA Ref: 1721504-07/29/25-007R

Model: Refer to FSN

MHRA reference: 36823137 (https://mhra-gov.filecamp.com/s/d/SBs0xnYoXV1YKGHu) 2025/008/006/601/044

Stryker: Nasopore, Otopore

09 May 2025

RA2025-3888970

Model: Refer to FSN

MHRA reference: 35729161 (https://mhra-gov.filecamp.com/s/d/46mH7vg9hDAGOAUp) 2025/003/xx-xxxx-xxxx

Trinity Biotech: Premier Hb9210 HbA1c Analyzer

16 September 2025

FOLLOW-UP FSN – ref INCDT001-24-3

Update to FSN dated 25 Oct 2024 - MHRA reference: 33769421 (https://mhra-gov.filecamp.com/s/d/JzEwPp7Bv0u0JBl8)

Product Code: 42790

Model: Refer to FSN

MHRA reference: 36832689 (https://mhra-gov.filecamp.com/s/d/sG6QzrjGQQihzUjb) 2024/009/xx-xxxx-xxxx

W.L. Gore; Associates: GORE® ACUSEAL Vascular Graft

August 2025

Vascular Graft

Model: Refer to FSN

MHRA reference: 36813123 (https://mhra-gov.filecamp.com/s/d/oRiChUjbDWsHI3Gc) 2025/008/012/601/081