Safety communications

This page is for patients, the public and healthcare professionals.

It describes the different communications issued for device safety issues.

How is device safety information communicated?

There are two main types of safety communications:

  1. Field safety notices (FSNs), published by manufacturers.
  2. HPRA safety notices (SNs), published by us.

For more details on these communications, click the menu below. 

Field safety notices

Manufacturers must inform device users if they find a safety issue with their device.

Manufacturers issue FSNs to device users if they find a safety issue.

If your device is affected by a safety issue and you receive a FSN, read it carefully and follow the instructions.

FSNs may have key information or actions, such as:

  • Removal of a device from the market.
  • Updated instructions on how to use a device safely.
  • A patient recall (where patients are to be brought back for re-testing).

We publish a summary of FSNs affecting the Irish market during the first week of each month.

We also publish a list of FSNs circulated to the Irish market where actions remain outstanding.

We can only publish FSNs notified to us.

If you receive an FSN not on our list, please let us know by email at



HPRA safety notices

If you receive a FSN from a manufacturer, act on it at once.

Do not wait for a HPRA safety notice . Most FSNs are not accompanied by a HPRA safety notice.

We issue HPRA safety notices to device users when we consider it necessary.

This includes:

  • To give more information to users in Ireland (FSNs often accompany SNs).
  • To raise awareness of a high risk FSN.
  • To raise awareness of an FSN where the manufacturer has not been able to contact all device users.
  • Where a company no longer exists.

More details on our safety notices, including how they are formatted, can be found here.

Anyone can sign up to receive HPRA safety notice by emailing

What should I do if I receive a HPRA safety notice?

If you are a patient or member of the public, you should:

  • Review the safety notice.
  • Discuss any problems or concerns with your doctor.

If you are a healthcare professional, you should:

  • Ensure the notice reaches the correct person in your organisation.
  • Share the notice with other affected organisations or persons.
  • Review the notice and complete actions as needed.


Date Title Type
14/06/2019 Endo GIA Surgical Stapling Single Use Loading Units, Tri-Staple 2.0 Intelligent Reloads and Cartridges. Priority 1 – For Immediate Action For Immediate Action
07/06/2019 Medtronic Implantable Pacemaker & CRT-P Devices. Affected Models: Azure™, Astra™, Percepta™, Serena™, Solara™ . Priority 2 – Warning Warning
06/06/2019 Summary of Field Safety Notices - May 2019 3rd Party Publications
31/05/2019 Sheridan Close Fitting Endotracheal Tube,Sheridan Endotracheal Tube, Sheridan HVT Endotracheal Tube, Sheridan HVT EZ-Endo Endotracheal Tube, Sheridan Preformed Endotracheal Tube, Sheridan Uncuffed Endotracheal Tube. Priority 1 – For Immediate Action For Immediate Action
31/05/2019 Prismaflex and OXIRIS S sets – Risk of kinked line. Priority 2 – Warning Warning
27/05/2019 ThermaCare Lower Back & Hip Heatwraps. Priority 2 – Warning Warning
27/05/2019 Philips Efficia CM Monitors. Priority 2 – Warning Warning
27/05/2019 Philips PageWriter TC Cardiographs (TC20/30/50/70). Priority 2 – Warning Warning
21/05/2019 MAHURKAR Acute Triple Lumen Catheter; MAHURKAR Acute Dual Lumen Catheter; Argyle Acute Single Lumen Catheter. Priority 2 – Warning Warning
17/05/2019 ARCHITECT c4000 Mixer, ARCHITECT c8000 Mixer, ARCHITECT c16000 Mixer. Priority 2 – Warning Warning
02/05/2019 Paclitaxel-coated balloons and Paclitaxel-eluting stents used for peripheral artery disease. Priority 2 – Warning Warning
01/05/2019 Summary of Field Safety Notices - April 2019 3rd Party Publications
29/04/2019 Giraffe Bedded Warmer, Panda iRes Warmer. Priority 2 – Warning Warning
11/04/2019 Intraluminal Staplers Product Codes: ECS21A, ECS25A, ECS29A, ECS33A, CDH21A, CDH25A, CDH29A, CDH33A (specific lots). Priority 1 – For Immediate Action For Immediate Action
10/04/2019 Rebound HRD/HRD-V. Priority 2 – Warning Warning
09/04/2019 Biotin Interference. Priority 2 – Warning Warning
04/04/2019 Telefunken AED Models HR1 & FA1. Priority 2 – Warning Warning
02/04/2019 Summary of Field Safety Notices - March 2019 3rd Party Publications
01/03/2019 Summary of Field Safety Notices - February 2019 3rd Party Publications
01/03/2019 T34 Ambulatory Syringe Pumps -Update. Priority 2 – Warning Warning