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 devicesafety@hpra.ie.

 

 

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 devicesafety@hpra.ie.

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
13/12/2019 Philips HeartStart XL+ Defibrillator/Monitor Warning
03/12/2019 Summary of Field Safety Notices - November 2019 3rd Party Publications
14/11/2019 Sulfasalazine Interference with laboratory tests - Priority 2 – Warning Warning
12/11/2019 Convex Two-Piece Skin Barriers (Natura /Surfit /Combihesive Wafers). Priority 2 – Warning Warning
05/11/2019 Summary of Field Safety Notices - October 2019 3rd Party Publications
01/10/2019 T34 Ambulatory Syringe Pumps - Update. Priority 2 – Warning Warning
01/10/2019 Summary of Field Safety Notices - September 2019 3rd Party Publications
09/09/2019 Summary of Field Safety Notices - August 2019 3rd Party Publications
15/08/2019 Feeding Tubes, Nelaton Catheters, Levins Tubes, Rectal Catheter, Ryles Tubes, Suction Catheters, Stomach Tubes, Medical Packs. Priority 2 – Warning Warning
01/08/2019 Summary of Field Safety Notices - July 2019 3rd Party Publications
18/07/2019 Neutrogena Visibly Clear Light Therapy Acne Mask and Activator. Priority 1 – For Immediate Action For Immediate Action
16/07/2019 MiniMed™ Paradigm™ Series and MiniMedTM 508 Insulin Pumps. Priority 2 – Warning Warning
08/07/2019 HeartStart MRx (M3539A AC Power Module). Priority 2 – Warning Warning
03/07/2019 Counterfeit Regenyal Idea Body 1X20ML. Priority 2 – Warning Warning
01/07/2019 Summary of Field Safety Notices - June 2019 3rd Party Publications
26/06/2019 Lone Star® Single-Use Elastic Stays and CPO-6 Colpo-Pneumo Occluder. Priority 2 – Warning Warning
17/06/2019 Electro–Surge Limited Devices used in Electrosurgery Advisory
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