Field Safety Notices: 17 to 21 March 2025
Source: gov.uk (2025-03-26)

List of Field Safety Notices for 17 to 21 March 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/skzADGfAOXNY9ow2)

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 Medical: Amplatzer TorqVue LP Delivery System / Catheter

March 2025

Cardiac occluder delivery kit

Model: 9-TVLP4F90/060, 9-TVLP4F90/080, 9-TVLPC4F90/080

MHRA reference: 35933446 (https://mhra-gov.filecamp.com/s/d/cS5rXyhI7LxwvhcA) 2025/003/017/601/033

Arthrex INC: OATS® 2.0 Single-Use Set, 12 mm

R545

Orthopaedic osteotome

Model: ABS-8981-12S

MHRA reference: 35005107 (https://mhra-gov.filecamp.com/s/d/vhzWIJeO4nE4y6IZ) 2024/011/008/601/055

Beckman Coulter: DxC 500i Clinical Analyzer

7th March 2025

See section 8

MHRA reference: 35005098 (https://mhra-gov.filecamp.com/s/d/gSmAqAwq7XCuqhdd) 2025/003/014/601/032

MHRA reference: 35005098 (https://mhra-gov.filecamp.com/s/d/c0SeEoKJfjVzhaUy) 2025/003/014/601/032 – Vigilance response form

Beckman Coulter: DxC 500i Clinical Analyzer

13th March 2025

See Section 8

MHRA reference: 35028594 (https://mhra-gov.filecamp.com/s/d/9NlPWvd8OTxJn99F) 2025/003/018/601/085

MHRA reference: 35028594 (https://mhra-gov.filecamp.com/s/d/5xhSWeCQd7elaadn) 2025/003/018/601/085 – Vigilance response form

Caesarea Medical Electronics Limited: BodyGuardTM MultiPurpose Infusion Pump System

11th September 2024

Ambulatory non-insulin infusion pump, electronic

MHRA reference: 34870431 (https://mhra-gov.filecamp.com/s/d/ueJBTjzQVIQXeR9T) 2025/002/xx-xxxx-xxxx

Canon Medical Systems Corporation: Vantage Orian, Vantage Elan, Vantage Titan

14th March 2025

Full-body MRI system, superconducting magnet

Model: MRT-1550, MRT-2020, MRT-1504, MRT-2004

MHRA reference: 35014991 (https://mhra-gov.filecamp.com/s/d/AEODOWVbOwrWMqun) 2025/003/014/601/090

Covidien llc: Hugo™ RAS Arm Cart Assembly

March 2025

MHRA reference: 35046359 (https://mhra-gov.filecamp.com/s/d/5de7duONyp1nYPsb) 2025/001/xx-xxxx-xxxx

GE Healthcare: Please see section 8 Comments

FMI 85480

MHRA reference: 35040388 (https://mhra-gov.filecamp.com/s/d/v5mRu77DIRjyrq0d) 2025/003/019/601/023

GE Medical Systems LLC : Revolution CT and Revolution Apex series

FMI 25504

Full-body CT system

MHRA reference: 35025644 (https://mhra-gov.filecamp.com/s/d/ZRh4XNDapUPoAHZG) 2025/003/014/601/077

ICU Medical Inc: ProPort™ Plastic Implantable Ports

27th February 2025

Spinal port/catheter

Model: See FSN

MHRA reference: 35018979 (https://mhra-gov.filecamp.com/s/d/4ffE6Gbdjow2OrXu) 2025/002/xx-xxxx-xxxx

Medtronic Limited: Evolut PRO+, Evolut FX, Evolut FX+ Systems

March 2025

Transcatheter Aortic Valve

Model: EVPROPLUS-23, EVPROPLUS-26, EVPROPLUS-29, EVPROPLUS-34, EVOLUTFX-23, EVOLUTFX-26, EVOLUTFX-29, EVOLUTFX-34, EVFXPLUS-23, EVFXPLUS-26, EVFXPLUS-29, EVFXPLUS-34

MHRA reference: 35044823 (https://mhra-gov.filecamp.com/s/d/pCqi2cY4Rbi9BTnp) 2025/003/019/601/037

PendraCare International B.V: CLIMBER

FSCA 25-001

Vascular Guide Catheter

Model: EBU 3.5

MHRA reference: 35042141 (https://mhra-gov.filecamp.com/s/d/S1Lj1y8stS8RKLqs) 2025/002/xx-xxxx-xxxx - Letter

PFM medical: Kölner Drainage; Redon Bottle

30th March 2023

Manual wound suction syst; Closed-wound drainage

MHRA reference: 35005209 (https://mhra-gov.filecamp.com/s/d/nQUrnYIG4OykoGOR) 2023/004/011/601/007

Philips Medical Systems: Philips Allura and Azurion

13th January 2025

Interventional Fluoroscopic X-Ray System

Model: 722031722003722010722026722005

MHRA reference: 35026809 (https://mhra-gov.filecamp.com/s/d/BGdiUVOIAV9toYav) 2025/001/015/601/013

Radiometer Medical ApS : ABL90 FLEX and ABL90 FLEX PLUS Analyzer

11th March 2025

See section 8

Model: xx-xxxx-xxxx, xx-xxxx-xxxx

MHRA reference: 35056560 (https://mhra-gov.filecamp.com/s/d/XzZrbKNzSmb7zcLi) - Letter

Siemens Healthcare Diagnostics Inc: Atellica CH Revised C-Reactive Protein (RCRP)

March 2025

See comments

Model: N/A

MHRA reference: 35042868 (https://mhra-gov.filecamp.com/s/d/kD5ZzEWhpaBopeyg) 2025/003/013/601/080

Thoratec Corporation: HeartMate 3 Mobile Power Unit (MPU)

March 2025

Heart Ventricle Prosthesis

Model: 107758, 107758UK, L107758

MHRA reference: 35006306 (https://mhra-gov.filecamp.com/s/d/boQsmQonKNX6lqtc) 2025/003/013/601/040

Thoratec Corporation: HeartMate 3 Mobile Power Unit (MPU)

March 2025

Heart Ventricle Prosthesis

Model: 107758, 107758UK, L107758

MHRA reference: 35006368 (https://mhra-gov.filecamp.com/s/d/deK9G7ImMCxCPXJG) 2025/003/013/601/040 - Letter

Wright Medical Technology Inc: TENDON SPACER (SWANSON/HUNTER) 24CM X 3MM FLEXSPAN

RA2024-3843283

MHRA reference: 35006173 (https://mhra-gov.filecamp.com/s/d/j7XoahK6upbwTtEz) 2025/001/xx-xxxx-xxxx