Safety Notices

HPRA Safety Notice Communication

We publish notices relating to the safety and/or quality of medical devices. The issues covered by these notices will range from quality defect information to product recalls, to updated information on the appropriate usage of the medical devices.

View the current safety notices for medical devices below.

If you would like to receive copies of these notices at the time of publication via e-mail please forward an e-mail request to devicesafety@hpra.ie.

Learn more about HPRA safety notices.

Manufacturer's Field Safety Notices

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market.

The HPRA puts these notices on our website for information.

Learn more about field safety notices.

Field Safety Notices - Outstanding Actions

When a field safety notice is issued by a medical device manufacturer on the Irish market, the HPRA seek confirmation from the manufacturer that the required action has been completed. Sometimes, completion of the action is delayed or hampered due to issues experienced by the manufacturer. The HPRA publishes details of field safety notices that have been circulated to the Irish market for which action remains outstanding.

Learn more about field safety notices.

Date Title Type
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
04/02/2019 Nebuliser masks. Priority 1 – For Immediate Action For Immediate Action
01/02/2019 Eleganza de Luxe. Priority 2 – Warning Warning
01/02/2019 Summary of Field Safety Notices - January 2019 3rd Party Publications
30/01/2019 VITEK®2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards. Priority 2 – Warning Warning
28/01/2019 Graseby Syringe Drivers (MS16A & MS26) - Update. Priority 2 – Warning Warning
23/01/2019 MiniMed™ Mio™ Advance Infusion Sets. Priority 1 – For Immediate Action For Immediate Action
16/01/2019 Raindrop Near Vision Inlay. Priority 2 – Warning Warning
03/01/2019 Summary of Field Safety Notices - December 2018 3rd Party Publications
21/12/2018 Dash 3000/4000/5000, Solar 8000M/i, Solar 9500, B20i/B40i and CARESCAPE B450/B650/B850 patient monitors. Priority 2 – Warning Warning
18/12/2018 CoaguChek Test Strips for Self-Testing and Point of Care Use. Update. CoaguChek XS PT Test PST, CoaguChek XS PT Test, CoaguChek PT Test. Priority 2 – Warning Warning