Changeflow GovPing Pharma & Drug Safety Field Safety Notices: 6 to 10 April 2026
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Field Safety Notices: 6 to 10 April 2026

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Summary

MHRA published a weekly compilation of 15 Field Safety Notices (FSNs) for medical devices issued 6-10 April 2026. FSNs cover devices including gastric balloons, surgical systems, intraocular lenses, CT systems, and diagnostic equipment. MHRA notes it publishes FSNs for information only, and recipients must act on FSNs received directly from manufacturers.

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What changed

MHRA published a weekly compilation of Field Safety Notices covering the period 6-10 April 2026. The listing includes 15 FSNs for medical devices including the Allurion Elipse Gastric Balloon System, Boston Scientific POLARx devices, Edwards Lifesciences EVOQUE Tricuspid Delivery System, GE HealthCare Revolution Ascend CT system, Intuitive Surgical da Vinci X & Xi Surgical System, and multiple Medline angiographic products.\n\nHealthcare providers and medical device users should review this listing to identify any relevant FSNs affecting devices they use or manage. While MHRA publishes these FSNs for informational purposes only, recipients are reminded they must take action on any FSNs they receive directly from manufacturers. Questions about specific notices should be directed to the issuing manufacturer.

What to do next

  1. Act on any Field Safety Notices received directly from manufacturers
  2. Contact the manufacturer with questions about specific FSNs

Archived snapshot

Apr 13, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Field Safety Notices: 6 to 10 April 2026

List of Field Safety Notices for 6 to 10 April 2026.

From: Medicines and Healthcare products Regulatory Agency Published 13 April 2026 Message type: Field safety notice Issued: 13 April 2026

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

Allurion: Elipse Gastric Balloon System

27 March 2026

Balloon, gastric, appetite-suppressing

Model: 10D

MHRA reference: 39095450 2026/004/002/601/160

Bonree Medical: GenCath Open Suction Catheter

April 2026

MHRA reference: 39132092 2026/004/009/601/041

Boston Scientific: POLARx & POLARx FIT, POLARSHEATH, SMARTFREEZE

09 April 2026

MHRA reference: 39107001 2026/004/007/601/051

BVI Liège/ PhysIOL: PODEYE

09 April 2026

Intraocular Lens posterior chamber pseudophakic

Model: PODAGF+21.5, PODAGF+23.0, PODAGF+24.0

MHRA reference: 39124618 2026/004/003/601/045

Edwards Lifesciences: EVOQUE Tricuspid Delivery System

31 March 2026

Tricuspid transcatheter heart valve bioprosthesis

Model: 9850TDS

MHRA reference: 39063549 2026/003/026/601/112

GE HealthCare: Revolution Ascend

Ref 23015

Full-body CT system

MHRA reference: 39103793 2026/004/007/601/073

Intuitive Surgical: da Vinci X & Xi Surgical System

Ref ISIFA2026-01-C

Robotic Surgical System

Model: IS4000 Surgical System; IS4200 Surgical System

MHRA reference: 39122168 2026/004/008/601/069

Medline: Angiographic Control Syringe with Rotating Adaptor

09 April 2026 FSN-26-04

MHRA reference: 39131949 2026/004/009/601/055

Medline: Angiographic Control Syringe with Rotating Adaptor

09 April 2026 FSN-26/05

MHRA reference: 39133197 2026/004/009/601/024

Medline: Angiographic Control Syringe with Rotating Adaptor

Ref FSN-26-03

MHRA reference: 39137125 2026/004/009/601/047

MEQU: M Warmer

31 March 2026

Model: MWS201

MHRA reference: 39094898 2026/004/002/601/108

Merivaara: Q-Flow surgical lights

31 March 2026

Operating room light system

Model: Q-FLOW SOLO, Q-FLOW DUO, Q-FLOW TRIO, Q-FLOW QUAD, Q-FLOW MOBILE

MHRA reference: 39092943 2026/004/002/601/114

Rand: ILP HT

02 April 2026

Intravascular/intracavitary-circulation hyperthermia system set

MHRA reference: 38990822 2026/003/027/601/012

Remel: OXOID Agglutinating Sera, Salmonella 9-0

19 March 2026

MHRA reference: 39107701 2026/003/023/601/077

Renishaw Mayfield: neuromate stereotactic surgery system - Headholder

08 April 2026

MHRA reference: 39150197 2026/003/025/601/050

Updates to this page

Published 13 April 2026 Contents

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Pharma & Drug Safety

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Classification

Agency
MHRA
Published
April 13th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Medical device makers Healthcare providers Patients
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device safety monitoring Device Field Safety Notices Medical device adverse event reporting
Geographic scope
United Kingdom GB

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Product Safety

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