Safety communications

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.

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.