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
05/05/2021 Summary of Field Safety Notices - April 2021 3rd Party Publications
04/05/2021 Field Safety Notice Summary Sheet - Outstanding Actions 3rd Party Publications
01/04/2021 Summary of Field Safety Notices - March 2021 3rd Party Publications
01/04/2021 MiniMed 780G Insulin Pump System. Priority 2 – Warning Warning
12/03/2021 Infusion Sets for Alaris™ Pumps (GP, VP, CC, GW/GW800, SE, IVAC 590 series) and Gravity Infusion sets & connectors. Priority 1 – For Immediate Action For Immediate Action
03/03/2021 Summary of Field Safety Notices - February 2021 3rd Party Publications
25/02/2021 Emicizumab (Hemlibra®) interference with blood coagulation tests - Priority 2 – Warning Warning
02/02/2021 Summary of Field Safety Notices - January 2021 3rd Party Publications
27/01/2021 Various Endotherapy products - Priority 1 – For Immediate Action For Immediate Action
04/01/2021 Summary of Field Safety Notices - December 2020 3rd Party Publications
03/12/2020 Summary of Field Safety Notices - November 2020 3rd Party Publications
03/11/2020 Summary of Field Safety Notices - October 2020 3rd Party Publications
02/11/2020 Contour Test Strips / Contour TS Test Strips 50. Priority 1 – For Immediate Action For Immediate Action
02/10/2020 Summary of Field Safety Notices - September 2020 3rd Party Publications
24/09/2020 LAP-BAND Adjustable Gastric Banding System and Accessories. Priority 3 – Advisory Advisory
02/09/2020 Summary of Field Safety Notices - August 2020 3rd Party Publications
26/08/2020 Covidien Endo GIA™ Auto Suture™ universal articulating loading units, Priority 1 – For Immediate Action For Immediate Action
19/08/2020 Datascope/Getinge/Maquet Intra-Aortic Balloon Catheters: Priority 2 – Warning Warning
13/08/2020 TOP-Q Super Fine Line, TOP-Q Super Derm Line, TOP-Q Super Deep Line. Priority 2 – Warning Warning
10/08/2020 Lifepak 500 Automated External Defibrillator. Priority 2 – Warning Warning