My HPRA: Register

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:

Field safety notices (FSNs), published by manufacturers.
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.

Order by:

Show:

Date	Title	Type
03/06/2016	M2a 38mm Acetabular System. Priority 2 – Warning	Warning
02/06/2016	Summary of Field Safety Notices - May 2016	3rd Party Publications
02/06/2016	FLUOROCELL PLT. Priority 2 – Warning	Warning
12/05/2016	Counterfeit Prime & Bond NT Refill - Priority 3 - Advisory Update	Advisory
03/05/2016	Summary of Field Safety Notice – April 2016	3rd Party Publications
29/04/2016	Zelos PTA Balloon Catheter. Priority 1 – For Immediate Action	For Immediate Action
29/04/2016	Endobon Xenograft Granules. Priority 2 – Warning	Warning
29/04/2016	LOVEXOK One Step Pregnancy (HCG) Test Strips. Priority 2 – Warning	Advisory
25/04/2016	Cross Reactivity Of Fulvestrant in Estradiol Assays. Priority 3 – Advisory.	Advisory
07/04/2016	Risk associated with Wall mounted and Ceiling mounted Devices. Priority 3 – Advisory	Advisory
04/04/2016	Summary of Field Safety Notice – March 2016	3rd Party Publications
15/03/2016	G4 PLATINUM and G5 Mobile Receivers. Priority 2 – Warning	Warning
03/03/2016	Summary of Field Safety Notices - February 2016	3rd Party Publications
09/02/2016	Contour NEXT Control Solution. Priority 2 – Warning	Warning
02/02/2016	CME Syringe Extension Sets and T34 Ambulatory Syringe Pumps. Priority 2 – Warning	Warning
02/02/2016	Summary of Field Safety Notice – January 2016	3rd Party Publications
28/01/2016	Smith & Nephew Birmingham Hip Modular Head. Priority 2 – Warning	Warning
22/01/2016	Magnetom Systems – Superconducting Magnets. Priority 2 – Warning	Warning
08/01/2016	Manufacturer Field Safety Notices & HPRA Safety Notices. Priority 3 – Advisory	Advisory
05/01/2016	Summary of Field Safety Notices – December 2015	3rd Party Publications