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
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 Field Safety Notice Summary Sheet - Outstanding Actions 3rd Party Publications
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